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ACUSON Sequoia Select Diagnostic Ultrasound System

Model 11658635 · SIEMENS MEDICAL SOLUTIONS USA, INC. · DI 04056869981062

ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570

IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550

IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560

QIH — Automated Radiological Image Processing Software · Class II · 21 CFR 892.2050

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

4913182019-01: 0 reports for this device; peer average 3.15/device2019-02: 0 reports for this device; peer average 5.46/device2019-03: 0 reports for this device; peer average 5.81/device2019-04: 0 reports for this device; peer average 3.3/device2019-05: 0 reports for this device; peer average 5.27/device2019-06: 0 reports for this device; peer average 6.28/device2019-07: 0 reports for this device; peer average 5.59/device2019-08: 0 reports for this device; peer average 7.45/device2019-09: 0 reports for this device; peer average 3.92/device2019-10: 0 reports for this device; peer average 3.57/device2019-11: 0 reports for this device; peer average 4.04/device2019-12: 0 reports for this device; peer average 4.84/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 5.41/device2020-03: 0 reports for this device; peer average 5.5/device2020-04: 0 reports for this device; peer average 5.17/device2020-05: 0 reports for this device; peer average 2.86/device2020-06: 0 reports for this device; peer average 3.16/device2020-07: 0 reports for this device; peer average 4.28/device2020-08: 0 reports for this device; peer average 2.95/device2020-09: 0 reports for this device; peer average 2.07/device2020-10: 0 reports for this device; peer average 3.79/device2020-11: 0 reports for this device; peer average 3.95/device2020-12: 0 reports for this device; peer average 5.84/device2021-01: 0 reports for this device; peer average 6.46/device2021-02: 0 reports for this device; peer average 4.57/device2021-03: 0 reports for this device; peer average 7.36/device2021-04: 0 reports for this device; peer average 4.15/device2021-05: 0 reports for this device; peer average 5.98/device2021-06: 0 reports for this device; peer average 6.38/device2021-07: 0 reports for this device; peer average 8.37/device2021-08: 0 reports for this device; peer average 7.16/device2021-09: 0 reports for this device; peer average 9.35/device2021-10: 0 reports for this device; peer average 5.7/device2021-11: 0 reports for this device; peer average 6.88/device2021-12: 0 reports for this device; peer average 9.64/device2022-01: 0 reports for this device; peer average 6.42/device2022-02: 0 reports for this device; peer average 8.25/device2022-03: 0 reports for this device; peer average 7.19/device2022-04: 0 reports for this device; peer average 8.11/device2022-05: 0 reports for this device; peer average 9.67/device2022-06: 0 reports for this device; peer average 7.56/device2022-07: 0 reports for this device; peer average 7.46/device2022-08: 0 reports for this device; peer average 5.42/device2022-09: 0 reports for this device; peer average 4.69/device2022-10: 0 reports for this device; peer average 4.41/device2022-11: 0 reports for this device; peer average 4.26/device2022-12: 0 reports for this device; peer average 5/device2023-01: 0 reports for this device; peer average 4.86/device2023-02: 0 reports for this device; peer average 4.32/device2023-03: 0 reports for this device; peer average 5.68/device2023-04: 0 reports for this device; peer average 3.67/device2023-05: 0 reports for this device; peer average 6.07/device2023-06: 0 reports for this device; peer average 3.98/device2023-07: 0 reports for this device; peer average 4.1/device2023-08: 0 reports for this device; peer average 5.79/device2023-09: 0 reports for this device; peer average 5.64/device2023-10: 0 reports for this device; peer average 6.69/device2023-11: 0 reports for this device; peer average 5.33/device2023-12: 0 reports for this device; peer average 5.38/device2024-01: 0 reports for this device; peer average 6.28/device2024-02: 0 reports for this device; peer average 4.21/device2024-03: 0 reports for this device; peer average 5.91/device2024-04: 0 reports for this device; peer average 5.78/device2024-05: 0 reports for this device; peer average 4.13/device2024-06: 0 reports for this device; peer average 5.82/device2024-07: 0 reports for this device; peer average 4.89/device2024-08: 0 reports for this device; peer average 5.36/device2024-09: 0 reports for this device; peer average 5.68/device2024-10: 0 reports for this device; peer average 6.33/device2024-11: 0 reports for this device; peer average 4.01/device2024-12: 0 reports for this device; peer average 10.92/device2025-01: 0 reports for this device; peer average 4.24/device2025-02: 0 reports for this device; peer average 3.95/device2025-03: 0 reports for this device; peer average 5.58/device2025-04: 0 reports for this device; peer average 3.17/device2025-05: 0 reports for this device; peer average 3.81/device2025-06: 0 reports for this device; peer average 3.99/device2025-07: 0 reports for this device; peer average 4.02/device2025-08: 0 reports for this device; peer average 5.35/device2025-09: 0 reports for this device; peer average 6.24/device2025-10: 0 reports for this device; peer average 9.28/device2025-11: 0 reports for this device; peer average 11.71/device2025-12: 0 reports for this device; peer average 17.73/device2026-01: 0 reports for this device; peer average 11.09/device2026-02: 0 reports for this device; peer average 6.39/device2026-03: 0 reports for this device; peer average 8.18/device2026-04: 0 reports for this device; peer average 11.29/device2026-05: 0 reports for this device; peer average 15.73/device2026-06: 0 reports for this device; peer average 14.74/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.15
2019-0205.46
2019-0305.81
2019-0403.3
2019-0505.27
2019-0606.28
2019-0705.59
2019-0807.45
2019-0903.92
2019-1003.57
2019-1104.04
2019-1204.84
2020-0102.75
2020-0205.41
2020-0305.5
2020-0405.17
2020-0502.86
2020-0603.16
2020-0704.28
2020-0802.95
2020-0902.07
2020-1003.79
2020-1103.95
2020-1205.84
2021-0106.46
2021-0204.57
2021-0307.36
2021-0404.15
2021-0505.98
2021-0606.38
2021-0708.37
2021-0807.16
2021-0909.35
2021-1005.7
2021-1106.88
2021-1209.64
2022-0106.42
2022-0208.25
2022-0307.19
2022-0408.11
2022-0509.67
2022-0607.56
2022-0707.46
2022-0805.42
2022-0904.69
2022-1004.41
2022-1104.26
2022-1205
2023-0104.86
2023-0204.32
2023-0305.68
2023-0403.67
2023-0506.07
2023-0603.98
2023-0704.1
2023-0805.79
2023-0905.64
2023-1006.69
2023-1105.33
2023-1205.38
2024-0106.28
2024-0204.21
2024-0305.91
2024-0405.78
2024-0504.13
2024-0605.82
2024-0704.89
2024-0805.36
2024-0905.68
2024-1006.33
2024-1104.01
2024-12010.92
2025-0104.24
2025-0203.95
2025-0305.58
2025-0403.17
2025-0503.81
2025-0603.99
2025-0704.02
2025-0805.35
2025-0906.24
2025-1009.28
2025-11011.71
2025-12017.73
2026-01011.09
2026-0206.39
2026-0308.18
2026-04011.29
2026-05015.73
2026-06014.74
This device (reports/month)Average device in ITX, IYN, IYO, QIH (reports/device/month)

Regulatory clearances

  • K260844 SESE 2026-06-16 (k number procode)
  • K251481 SESE 2025-08-20 (k number procode)
  • K242523 SESE 2024-11-19 (k number procode)
  • K240704 SESE 2024-07-22 (k number procode)
  • K232145 SESE 2023-10-30 (k number procode)
  • K223735 SESE 2023-02-06 (k number procode)

Predicate lineage

K223735 — cites (transitively): K221500 (d1), K210743 (d2), K211859 (d2), K172162 (d3), K191922 (d3), K201462 (d3), K183575 (d3), K081148 (d4), K130739 (d4), K130881 (d4), K131164 (d4), K132165 (d4), K162243 (d4), K163635 (d4), K103411 (d4), K181547 (d4), K180039 (d4), K180067 (d4), K187357 (d4), K200707 (d4), K072998 (d5), K121138 (d5), K121329 (d5), K112255 (d5), K122825 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K082142 (d5), K090334 (d5), K093812 (d5), K111674 (d5), K152369 (d5), K141846 (d5), K163396 (d5), K170315 (d5), K123806 (d5), K150239 (d5), K150949 (d5), K160524 (d5), K172142 (d5), K173034 (d5), K193257 (d5), K033650 (d6), K042593 (d6), K063085 (d6), K063803 (d6), K072786 (d6), K071234 (d6), K091970 (d6), K102041 (d6), K022567 (d6), K032114 (d6), K093563 (d6), K112596 (d6), K121699 (d6), K123001 (d6), K132804 (d6), K132274 (d6), K142517 (d6), K142876 (d6), K121062 (d6), K150050 (d6), K161787 (d6), K162221 (d6), K162417 (d6), K021966 (d7), K023877 (d7), K030455 (d7), K992631 (d7), K014206 (d7), K080760 (d7), K090276 (d7), K093531 (d7), K101091 (d7), K102997 (d7), K093612 (d7), K116174 (d7), K123622 (d7), K130619 (d7), K123209 (d7), K133761 (d7), K140959 (d7), K152469 (d7), K142628 (d7), K100598 (d7), K082430 (d8), K023931 (d8), K052331 (d8), K022858 (d8), K053069 (d8), K062247 (d8), K073709 (d8), K082326 (d8), K080935 (d8), K083095 (d8), K093462 (d8), K080555 (d8), K070242 (d8), K072365 (d8), K102017 (d8), K113179 (d8), K122826 (d8), K123992 (d8), K132654 (d8) — cited as predicate by K232145

K232145 — cites (transitively): K211726 (d1), K223735 (d1), K171766 (d2), K202683 (d2), K221500 (d2), K170315 (d3), K141846 (d3), K150050 (d3), K161787 (d3), K162243 (d3), K162417 (d3), K163396 (d3), K172162 (d3), K180039 (d3), K180067 (d3), K183575 (d3), K187357 (d3), K191922 (d3), K192835 (d3), K200585 (d3), K200644 (d3), K200707 (d3), K201012 (d3), K201130 (d3), K201462 (d3), K210743 (d3), K211859 (d3), K112596 (d4), K121699 (d4), K123001 (d4), K132804 (d4), K140959 (d4), K152469 (d4), K081148 (d4), K082142 (d4), K090334 (d4), K093812 (d4), K111674 (d4), K121138 (d4), K152369 (d4), K100598 (d4), K121062 (d4), K162221 (d4), K130739 (d4), K130881 (d4), K131164 (d4), K132165 (d4), K163635 (d4), K103411 (d4), K181547 (d4), K173957 (d4), K181098 (d4), K193257 (d4), K162329 (d4), K182857 (d4), K191647 (d4), K192226 (d4), K033650 (d5), K042593 (d5), K063085 (d5), K063803 (d5), K072786 (d5), K023931 (d5), K052331 (d5), K072998 (d5), K071234 (d5), K992631 (d5), K022567 (d5), K032114 (d5), K014206 (d5), K080760 (d5), K090276 (d5), K093531 (d5), K101091 (d5), K102997 (d5), K121329 (d5), K112255 (d5), K122825 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K093612 (d5), K116174 (d5), K123622 (d5), K130619 (d5), K142876 (d5), K142628 (d5), K120321 (d5), K121381 (d5), K123754 (d5), K160807 (d5), K112050 (d5), K140318 (d5), K170992 (d5), K173618 (d5), K123806 (d5), K150239 (d5), K150949 (d5), K160524 (d5), K172142 (d5), K173034 (d5), K150122 (d5), K151022 (d5), K181485 (d5), K181264 (d5), K162549 (d5), K082430 (d6), K022858 (d6), K053069 (d6), K062247 (d6), K073709 (d6), K082326 (d6), K080935 (d6), K083095 (d6), K093462 (d6), K070242 (d6), K092064 (d6), K091970 (d6), K102041 (d6), K043535 (d6), K093563 (d6), K072365 (d6), K102017 (d6), K113179 (d6), K030455 (d6), K091804 (d6), K122826 (d6), K132654 (d6), K110667 (d6), K132544 (d6), K132274 (d6), K142517 (d6), K082094 (d6), K983436 (d6), K081661 (d6), K121498 (d6), K130159 (d6), K132304 (d6), K152899 (d6), K153480 (d6), K081808 (d6), K163478 (d6), K171314 (d6), K172607 (d6), K021966 (d7), K023877 (d7), K001400 (d7), K051139 (d7), K061995 (d7), K083348 (d7), K053610 (d7), K080891 (d7), K040227 (d7), K042293 (d7), K130499 (d7), K071232 (d7), K090461 (d7), K103782 (d7), K120135 (d7), K122289 (d7), K130754 (d7), K123209 (d7), K133761 (d7), K133833 (d7), K130304 (d7), K141261 (d7), K121781 (d7), K163120 (d7), K100352 (d8), K080555 (d8), K051993 (d8), K904834 (d8), K991580 (d8), K123992 (d8), K070907 (d8), K101874 (d8), K131527 (d8), K142100 (d8) — cited as predicate by K240704, K243235, K243299, K251110

K240704 — cites (transitively): K232145 (d1), K233270 (d1), K233613 (d1), K211726 (d2), K223735 (d2), K170263 (d2), K240050 (d2), K071234 (d3), K171766 (d3), K202683 (d3), K221500 (d3), K112050 (d3), K070242 (d4), K092064 (d4), K170315 (d4), K141846 (d4), K150050 (d4), K161787 (d4), K162243 (d4), K162417 (d4), K163396 (d4), K172162 (d4), K180039 (d4), K180067 (d4), K183575 (d4), K187357 (d4), K191922 (d4), K192835 (d4), K200585 (d4), K200644 (d4), K200707 (d4), K201012 (d4), K201130 (d4), K201462 (d4), K210743 (d4), K211859 (d4), K112596 (d5), K121699 (d5), K123001 (d5), K132804 (d5), K140959 (d5), K152469 (d5), K081148 (d5), K082142 (d5), K090334 (d5), K093812 (d5), K111674 (d5), K121138 (d5), K152369 (d5), K100598 (d5), K121062 (d5), K162221 (d5), K130739 (d5), K130881 (d5), K131164 (d5), K132165 (d5), K163635 (d5), K103411 (d5), K181547 (d5), K173957 (d5), K181098 (d5), K193257 (d5), K162329 (d5), K182857 (d5), K191647 (d5), K192226 (d5), K033650 (d6), K042593 (d6), K063085 (d6), K063803 (d6), K072786 (d6), K023931 (d6), K052331 (d6), K072998 (d6), K992631 (d6), K022567 (d6), K032114 (d6), K014206 (d6), K080760 (d6), K090276 (d6), K093531 (d6), K101091 (d6), K102997 (d6), K121329 (d6), K112255 (d6), K122825 (d6), K042540 (d6), K070792 (d6), K120525 (d6), K093612 (d6), K116174 (d6), K123622 (d6), K130619 (d6), K142876 (d6), K142628 (d6), K120321 (d6), K121381 (d6), K123754 (d6), K160807 (d6), K140318 (d6), K170992 (d6), K173618 (d6), K123806 (d6), K150239 (d6), K150949 (d6), K160524 (d6), K172142 (d6), K173034 (d6), K150122 (d6), K151022 (d6), K181485 (d6), K181264 (d6), K162549 (d6), K082430 (d7), K022858 (d7), K053069 (d7), K062247 (d7), K073709 (d7), K082326 (d7), K080935 (d7), K083095 (d7), K093462 (d7), K091970 (d7), K102041 (d7), K043535 (d7), K093563 (d7), K072365 (d7), K102017 (d7), K113179 (d7), K030455 (d7), K091804 (d7), K122826 (d7), K132654 (d7), K110667 (d7), K132544 (d7), K132274 (d7), K142517 (d7), K082094 (d7), K983436 (d7), K081661 (d7), K121498 (d7), K130159 (d7), K132304 (d7), K152899 (d7), K153480 (d7), K081808 (d7), K163478 (d7), K171314 (d7), K172607 (d7), K021966 (d8), K023877 (d8), K001400 (d8), K051139 (d8), K061995 (d8), K083348 (d8), K053610 (d8), K080891 (d8), K040227 (d8), K042293 (d8), K130499 (d8), K071232 (d8), K090461 (d8), K103782 (d8), K120135 (d8), K122289 (d8), K130754 (d8), K123209 (d8), K133761 (d8), K133833 (d8), K130304 (d8), K141261 (d8), K121781 (d8), K163120 (d8) — cited as predicate by K242523

K242523 — cites (transitively): K230207 (d1), K240704 (d1), K183575 (d2), K213487 (d2), K221190 (d2), K232145 (d2), K233270 (d2), K233613 (d2), K081148 (d3), K103411 (d3), K130739 (d3), K130881 (d3), K131164 (d3), K172162 (d3), K181547 (d3), K163396 (d3), K201130 (d3), K210743 (d3), K211726 (d3), K223735 (d3), K170263 (d3), K240050 (d3), K072998 (d4), K121138 (d4), K121329 (d4), K112255 (d4), K122825 (d4), K121062 (d4), K141846 (d4), K150050 (d4), K161787 (d4), K162221 (d4), K162417 (d4), K071234 (d4), K132165 (d4), K162243 (d4), K163635 (d4), K123806 (d4), K150239 (d4), K150949 (d4), K160524 (d4), K172142 (d4), K173034 (d4), K180039 (d4), K191922 (d4), K193257 (d4), K201462 (d4), K171766 (d4), K202683 (d4), K221500 (d4), K112050 (d4), K070242 (d5), K092064 (d5), K091970 (d5), K102041 (d5), K022567 (d5), K032114 (d5), K033650 (d5), K042593 (d5), K063085 (d5), K063803 (d5), K072786 (d5), K082142 (d5), K090334 (d5), K093812 (d5), K111674 (d5), K093563 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K112596 (d5), K121699 (d5), K123001 (d5), K132804 (d5), K140959 (d5), K132274 (d5), K142517 (d5), K152469 (d5), K142628 (d5), K152369 (d5), K100598 (d5), K170315 (d5), K180067 (d5), K187357 (d5), K200707 (d5), K192835 (d5), K200585 (d5), K200644 (d5), K201012 (d5), K211859 (d5), K021966 (d6), K023877 (d6), K030455 (d6), K023931 (d6), K052331 (d6), K992631 (d6), K014206 (d6), K080760 (d6), K090276 (d6), K093531 (d6), K101091 (d6), K102997 (d6), K093612 (d6), K116174 (d6), K123622 (d6), K130619 (d6), K123209 (d6), K133761 (d6), K132654 (d6), K142876 (d6), K173957 (d6), K181098 (d6), K162329 (d6), K182857 (d6), K191647 (d6), K192226 (d6), K082430 (d7), K022858 (d7), K053069 (d7), K062247 (d7), K073709 (d7), K082326 (d7), K080935 (d7), K083095 (d7), K093462 (d7), K080555 (d7), K072365 (d7), K102017 (d7), K113179 (d7), K122826 (d7), K130754 (d7), K123992 (d7), K120321 (d7), K121381 (d7), K123754 (d7), K160807 (d7), K140318 (d7), K170992 (d7), K173618 (d7), K150122 (d7), K151022 (d7), K181485 (d7), K181264 (d7), K162549 (d7), K001400 (d8), K051139 (d8), K043535 (d8), K080891 (d8), K091804 (d8), K103629 (d8), K121422 (d8), K110667 (d8), K132544 (d8), K082094 (d8), K983436 (d8), K081661 (d8), K121498 (d8), K130159 (d8), K132304 (d8), K152899 (d8), K153480 (d8), K081808 (d8), K163478 (d8), K171314 (d8), K172607 (d8) — cited as predicate by K251481

K251481 — cites (transitively): K242523 (d1), K230207 (d2), K240704 (d2), K183575 (d3), K213487 (d3), K221190 (d3), K232145 (d3), K233270 (d3), K233613 (d3), K081148 (d4), K103411 (d4), K130739 (d4), K130881 (d4), K131164 (d4), K172162 (d4), K181547 (d4), K163396 (d4), K201130 (d4), K210743 (d4), K211726 (d4), K223735 (d4), K170263 (d4), K240050 (d4), K072998 (d5), K121138 (d5), K121329 (d5), K112255 (d5), K122825 (d5), K121062 (d5), K141846 (d5), K150050 (d5), K161787 (d5), K162221 (d5), K162417 (d5), K071234 (d5), K132165 (d5), K162243 (d5), K163635 (d5), K123806 (d5), K150239 (d5), K150949 (d5), K160524 (d5), K172142 (d5), K173034 (d5), K180039 (d5), K191922 (d5), K193257 (d5), K201462 (d5), K171766 (d5), K202683 (d5), K221500 (d5), K112050 (d5), K070242 (d6), K092064 (d6), K091970 (d6), K102041 (d6), K022567 (d6), K032114 (d6), K033650 (d6), K042593 (d6), K063085 (d6), K063803 (d6), K072786 (d6), K082142 (d6), K090334 (d6), K093812 (d6), K111674 (d6), K093563 (d6), K042540 (d6), K070792 (d6), K120525 (d6), K112596 (d6), K121699 (d6), K123001 (d6), K132804 (d6), K140959 (d6), K132274 (d6), K142517 (d6), K152469 (d6), K142628 (d6), K152369 (d6), K100598 (d6), K170315 (d6), K180067 (d6), K187357 (d6), K200707 (d6), K192835 (d6), K200585 (d6), K200644 (d6), K201012 (d6), K211859 (d6), K021966 (d7), K023877 (d7), K030455 (d7), K023931 (d7), K052331 (d7), K992631 (d7), K014206 (d7), K080760 (d7), K090276 (d7), K093531 (d7), K101091 (d7), K102997 (d7), K093612 (d7), K116174 (d7), K123622 (d7), K130619 (d7), K123209 (d7), K133761 (d7), K132654 (d7), K142876 (d7), K173957 (d7), K181098 (d7), K162329 (d7), K182857 (d7), K191647 (d7), K192226 (d7), K082430 (d8), K022858 (d8), K053069 (d8), K062247 (d8), K073709 (d8), K082326 (d8), K080935 (d8), K083095 (d8), K093462 (d8), K080555 (d8), K072365 (d8), K102017 (d8), K113179 (d8), K122826 (d8), K130754 (d8), K123992 (d8), K120321 (d8), K121381 (d8), K123754 (d8), K160807 (d8), K140318 (d8), K170992 (d8), K173618 (d8), K150122 (d8), K151022 (d8), K181485 (d8), K181264 (d8), K162549 (d8) — cited as predicate by K253487, K260844

K260844 — cites (transitively): K233613 (d1), K251481 (d1), K211726 (d2), K233270 (d2), K240050 (d2), K242523 (d2), K171766 (d3), K202683 (d3), K170263 (d3), K112050 (d3), K230207 (d3), K240704 (d3), K070242 (d4), K092064 (d4), K071234 (d4), K170315 (d4), K141846 (d4), K150050 (d4), K161787 (d4), K162243 (d4), K162417 (d4), K163396 (d4), K172162 (d4), K180039 (d4), K180067 (d4), K183575 (d4), K187357 (d4), K191922 (d4), K192835 (d4), K200585 (d4), K200644 (d4), K200707 (d4), K201012 (d4), K201130 (d4), K201462 (d4), K213487 (d4), K221190 (d4), K232145 (d4), K112596 (d5), K121699 (d5), K123001 (d5), K132804 (d5), K140959 (d5), K152469 (d5), K081148 (d5), K082142 (d5), K090334 (d5), K093812 (d5), K111674 (d5), K121138 (d5), K152369 (d5), K100598 (d5), K121062 (d5), K162221 (d5), K130739 (d5), K130881 (d5), K131164 (d5), K132165 (d5), K163635 (d5), K103411 (d5), K181547 (d5), K173957 (d5), K181098 (d5), K193257 (d5), K162329 (d5), K182857 (d5), K191647 (d5), K192226 (d5), K210743 (d5), K223735 (d5), K033650 (d6), K042593 (d6), K063085 (d6), K063803 (d6), K072786 (d6), K023931 (d6), K052331 (d6), K072998 (d6), K992631 (d6), K022567 (d6), K032114 (d6), K014206 (d6), K080760 (d6), K090276 (d6), K093531 (d6), K101091 (d6), K102997 (d6), K121329 (d6), K112255 (d6), K122825 (d6), K042540 (d6), K070792 (d6), K120525 (d6), K093612 (d6), K116174 (d6), K123622 (d6), K130619 (d6), K142876 (d6), K142628 (d6), K120321 (d6), K121381 (d6), K123754 (d6), K160807 (d6), K140318 (d6), K170992 (d6), K173618 (d6), K123806 (d6), K150239 (d6), K150949 (d6), K160524 (d6), K172142 (d6), K173034 (d6), K150122 (d6), K151022 (d6), K181485 (d6), K181264 (d6), K162549 (d6), K221500 (d6), K082430 (d7), K022858 (d7), K053069 (d7), K062247 (d7), K073709 (d7), K082326 (d7), K080935 (d7), K083095 (d7), K093462 (d7), K091970 (d7), K102041 (d7), K043535 (d7), K093563 (d7), K072365 (d7), K102017 (d7), K113179 (d7), K030455 (d7), K091804 (d7), K122826 (d7), K132654 (d7), K110667 (d7), K132544 (d7), K132274 (d7), K142517 (d7), K082094 (d7), K983436 (d7), K081661 (d7), K121498 (d7), K130159 (d7), K132304 (d7), K152899 (d7), K153480 (d7), K081808 (d7), K163478 (d7), K171314 (d7), K172607 (d7), K211859 (d7), K021966 (d8), K023877 (d8), K001400 (d8), K051139 (d8), K061995 (d8), K083348 (d8), K053610 (d8), K080891 (d8), K040227 (d8), K042293 (d8), K130499 (d8), K071232 (d8), K090461 (d8), K103782 (d8), K120135 (d8), K122289 (d8), K130754 (d8), K123209 (d8), K133761 (d8), K133833 (d8), K130304 (d8), K141261 (d8), K121781 (d8), K163120 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — SIEMENS MEDICAL SOLUTIONS USA, INC.

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  • VAI 2016-04-15 Siemens Medical Solutions USA, Inc. · 2 citations
  • NAI 2015-09-09 Siemens Medical Solutions USA, Inc. · 0 citations
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