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Diagnostic Ultrasound System

Model Operus M11 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06903053016544

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

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.

5914192019-01: 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 2.89/device2020-06: 0 reports for this device; peer average 3.16/device2020-07: 0 reports for this device; peer average 4.32/device2020-08: 0 reports for this device; peer average 2.93/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 4.01/device2020-12: 0 reports for this device; peer average 5.87/device2021-01: 0 reports for this device; peer average 6.53/device2021-02: 0 reports for this device; peer average 4.61/device2021-03: 0 reports for this device; peer average 7.44/device2021-04: 0 reports for this device; peer average 4.17/device2021-05: 0 reports for this device; peer average 5.98/device2021-06: 0 reports for this device; peer average 6.44/device2021-07: 0 reports for this device; peer average 8.34/device2021-08: 0 reports for this device; peer average 7.22/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 6.49/device2022-02: 0 reports for this device; peer average 8.37/device2022-03: 0 reports for this device; peer average 7.24/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 4.73/device2022-10: 0 reports for this device; peer average 4.62/device2022-11: 0 reports for this device; peer average 4.41/device2022-12: 0 reports for this device; peer average 5.16/device2023-01: 0 reports for this device; peer average 5.01/device2023-02: 0 reports for this device; peer average 4.61/device2023-03: 0 reports for this device; peer average 5.75/device2023-04: 0 reports for this device; peer average 3.78/device2023-05: 0 reports for this device; peer average 6.15/device2023-06: 0 reports for this device; peer average 4.06/device2023-07: 0 reports for this device; peer average 4.25/device2023-08: 0 reports for this device; peer average 5.94/device2023-09: 0 reports for this device; peer average 5.7/device2023-10: 0 reports for this device; peer average 6.69/device2023-11: 0 reports for this device; peer average 5.36/device2023-12: 0 reports for this device; peer average 5.47/device2024-01: 0 reports for this device; peer average 6.28/device2024-02: 0 reports for this device; peer average 4.31/device2024-03: 0 reports for this device; peer average 5.97/device2024-04: 0 reports for this device; peer average 5.86/device2024-05: 0 reports for this device; peer average 4.16/device2024-06: 0 reports for this device; peer average 5.85/device2024-07: 0 reports for this device; peer average 4.97/device2024-08: 0 reports for this device; peer average 5.4/device2024-09: 0 reports for this device; peer average 5.79/device2024-10: 0 reports for this device; peer average 6.4/device2024-11: 0 reports for this device; peer average 4.03/device2024-12: 0 reports for this device; peer average 11.27/device2025-01: 0 reports for this device; peer average 4.34/device2025-02: 0 reports for this device; peer average 4.03/device2025-03: 0 reports for this device; peer average 5.83/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 3.93/device2025-06: 0 reports for this device; peer average 4.11/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 6.52/device2025-10: 0 reports for this device; peer average 9.71/device2025-11: 0 reports for this device; peer average 12.53/device2025-12: 0 reports for this device; peer average 18.81/device2026-01: 0 reports for this device; peer average 11.99/device2026-02: 0 reports for this device; peer average 6.63/device2026-03: 0 reports for this device; peer average 8.63/device2026-04: 0 reports for this device; peer average 11.88/device2026-05: 0 reports for this device; peer average 16.78/device2026-06: 0 reports for this device; peer average 15.26/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
2020-0502.89
2020-0603.16
2020-0704.32
2020-0802.93
2020-0902.07
2020-1003.79
2020-1104.01
2020-1205.87
2021-0106.53
2021-0204.61
2021-0307.44
2021-0404.17
2021-0505.98
2021-0606.44
2021-0708.34
2021-0807.22
2021-0909.35
2021-1005.7
2021-1106.88
2021-1209.64
2022-0106.49
2022-0208.37
2022-0307.24
2022-0408.11
2022-0509.67
2022-0607.56
2022-0707.46
2022-0805.42
2022-0904.73
2022-1004.62
2022-1104.41
2022-1205.16
2023-0105.01
2023-0204.61
2023-0305.75
2023-0403.78
2023-0506.15
2023-0604.06
2023-0704.25
2023-0805.94
2023-0905.7
2023-1006.69
2023-1105.36
2023-1205.47
2024-0106.28
2024-0204.31
2024-0305.97
2024-0405.86
2024-0504.16
2024-0605.85
2024-0704.97
2024-0805.4
2024-0905.79
2024-1006.4
2024-1104.03
2024-12011.27
2025-0104.34
2025-0204.03
2025-0305.83
2025-0403.25
2025-0503.93
2025-0604.11
2025-0704.1
2025-0805.45
2025-0906.52
2025-1009.71
2025-11012.53
2025-12018.81
2026-01011.99
2026-0206.63
2026-0308.63
2026-04011.88
2026-05016.78
2026-06015.26
This device (reports/month)Average device in ITX, IYN, IYO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K210416 — cites (transitively): K171034 (d1), K192152 (d1), K192410 (d1), K200001 (d1), K201693 (d1), K203391 (d1), K093713 (d2), K152543 (d2), K161525 (d2), K162267 (d2), K170277 (d2), K970514 (d2), K171233 (d2), K173471 (d2), K181637 (d2), K181985 (d2), K190206 (d2), K160559 (d2), K171891 (d2), K181783 (d2), K180599 (d2), K180912 (d2), K183377 (d2), K071204 (d3), K882383 (d3), K121062 (d3), K132913 (d3), K141010 (d3), K143472 (d3), K150080 (d3), K150204 (d3), K142368 (d3), K131690 (d3), K152763 (d3), K160381 (d3), K153529 (d3), K160807 (d3), K081386 (d3), K151175 (d3), K153277 (d3), K162269 (d3), K163077 (d3), K160184 (d3), K163690 (d3), K151028 (d3), K161706 (d3), K163596 (d3), K170714 (d3), K140254 (d3), K171579 (d3), K160162 (d3), K170445 (d3), K173555 (d3), K180535 (d3), K172342 (d3), K162845 (d3), K121010 (d4), K122327 (d4), K120234 (d4), K132341 (d4), K022928 (d4), K032503 (d4), K032875 (d4), K033311 (d4), K040719 (d4), K063518 (d4), K093466 (d4), K102901 (d4), K110673 (d4), K122537 (d4), K130206 (d4), K130247 (d4), K130308 (d4), K130881 (d4), K131946 (d4), K134016 (d4), K140443 (d4), K140639 (d4), K131609 (d4), K132779 (d4), K113690 (d4), K133533 (d4), K150249 (d4), K132335 (d4), K142160 (d4), K061961 (d4), K133905 (d4), K142008 (d4), K113758 (d4), K143089 (d4), K150478 (d4), K151663 (d4), K152962 (d4), K141675 (d4), K142472 (d4), K152567 (d4), K141639 (d4), K043535 (d4), K081661 (d4), K120321 (d4), K121498 (d4), K130159 (d4), K132165 (d4), K132304 (d4), K140318 (d4), K150087 (d4), K160078 (d4), K160277 (d4), K152309 (d4), K140030 (d4), K152545 (d4), K152758 (d4), K160182 (d4), K161047 (d4), K152195 (d4), K160524 (d4), K142323 (d4), K102991 (d4), K072786 (d5), K072164 (d5), K083001 (d5), K100830 (d5), K093563 (d5), K103583 (d5), K103677 (d5), K113647 (d5), K053610 (d5), K072285 (d5), K040227 (d5), K042293 (d5), K090196 (d5), K090197 (d5), K121138 (d5), K121329 (d5), K040762 (d5), K081518 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K130499 (d5), K108114 (d5), K123254 (d5), K101236 (d5), K120201 (d5), K123503 (d5), K130695 (d5), K131527 (d5), K100931 (d5), K103152 (d5), K123828 (d5), K120699 (d5), K130058 (d5), K120741 (d5), K051308 (d5), K052805 (d5), K060827 (d5), K081794 (d5), K091009 (d5), K110688 (d5), K111032 (d5), K111302 (d5), K132231 (d5), K132466 (d5), K140677 (d5), K123564 (d5), K132274 (d5), K121063 (d5), K131514 (d5), K141093 (d5), K130739 (d5), K132861 (d5), K133329 (d5), K141620 (d5), K120703 (d5), K141641 (d5), K112339 (d5), K133505 (d5), K142466 (d5), K143264 (d5), K021966 (d5), K130803 (d5), K131164 (d5), K141261 (d5), K143452 (d5), K133431 (d5), K142443 (d5), K103397 (d5), K133034 (d5), K141067 (d5), K141768 (d5), K150949 (d5), K023877 (d6), K030455 (d6), K072797 (d6), K051837 (d6), K061682 (d6), K092159 (d6), K093714 (d6), K093849 (d6), K032974 (d6), K050240 (d6), K052410 (d6), K060542 (d6), K060993 (d6), K101041 (d6), K053069 (d6), K072365 (d6), K091374 (d6), K092271 (d6), K090107 (d6), K091763 (d6), K050326 (d6), K101605 (d6), K063085 (d6), K101757 (d6), K112596 (d6), K102388 (d6), K073709 (d6), K082326 (d6), K101091 (d6), K053435 (d6), K103649 (d6), K071985 (d6), K082374 (d6), K092079 (d6), K022567 (d6), K032114 (d6), K033650 (d6), K042593 (d6), K063803 (d6), K071234 (d6), K081148 (d6), K082142 (d6), K090334 (d6), K093812 (d6), K111674 (d6), K102041 (d6), K081154 (d6), K100919 (d6), K122010 (d6), K111582 (d6), K122921 (d6), K093395 (d6), K110207 (d6), K112255 (d6), K122825 (d6), K031663 (d6), K120221 (d6), K122583 (d6), K130903 (d6), K101455 (d6), K121384 (d6), K060907 (d6), K101874 (d6), K050846 (d6), K031066 (d6), K123185 (d6), K130703 (d6), K131267 (d6), K092619 (d6), K132942 (d6), K132228 (d6), K123806 (d6), K142517 (d6), K070813 (d7), K043524 (d7), K022858 (d7), K062247 (d7), K020789 (d7), K060087 (d7), K094623 (d7), K083882 (d7), K092058 (d7), K043559 (d7), K071134 (d7), K082098 (d7), K073297 (d7), K091970 (d7), K033139 (d7), K041916 (d7), K043196 (d7), K992631 (d7), K090912 (d7), K090855 (d7), K100402 (d7), K123209 (d7), K133761 (d7), K080555 (d8), K123992 (d8) — cited as predicate by K212265, K212900, K230768

K230768 — cites (transitively): K210416 (d1), K171034 (d2), K192152 (d2), K192410 (d2), K200001 (d2), K201693 (d2), K203391 (d2), K093713 (d3), K152543 (d3), K161525 (d3), K162267 (d3), K170277 (d3), K970514 (d3), K171233 (d3), K173471 (d3), K181637 (d3), K181985 (d3), K190206 (d3), K160559 (d3), K171891 (d3), K181783 (d3), K180599 (d3), K180912 (d3), K183377 (d3), K071204 (d4), K882383 (d4), K121062 (d4), K132913 (d4), K141010 (d4), K143472 (d4), K150080 (d4), K150204 (d4), K142368 (d4), K131690 (d4), K152763 (d4), K160381 (d4), K153529 (d4), K160807 (d4), K081386 (d4), K151175 (d4), K153277 (d4), K162269 (d4), K163077 (d4), K160184 (d4), K163690 (d4), K151028 (d4), K161706 (d4), K163596 (d4), K170714 (d4), K140254 (d4), K171579 (d4), K160162 (d4), K170445 (d4), K173555 (d4), K180535 (d4), K172342 (d4), K162845 (d4), K121010 (d5), K122327 (d5), K120234 (d5), K132341 (d5), K022928 (d5), K032503 (d5), K032875 (d5), K033311 (d5), K040719 (d5), K063518 (d5), K093466 (d5), K102901 (d5), K110673 (d5), K122537 (d5), K130206 (d5), K130247 (d5), K130308 (d5), K130881 (d5), K131946 (d5), K134016 (d5), K140443 (d5), K140639 (d5), K131609 (d5), K132779 (d5), K113690 (d5), K133533 (d5), K150249 (d5), K132335 (d5), K142160 (d5), K061961 (d5), K133905 (d5), K142008 (d5), K113758 (d5), K143089 (d5), K150478 (d5), K151663 (d5), K152962 (d5), K141675 (d5), K142472 (d5), K152567 (d5), K141639 (d5), K043535 (d5), K081661 (d5), K120321 (d5), K121498 (d5), K130159 (d5), K132165 (d5), K132304 (d5), K140318 (d5), K150087 (d5), K160078 (d5), K160277 (d5), K152309 (d5), K140030 (d5), K152545 (d5), K152758 (d5), K160182 (d5), K161047 (d5), K152195 (d5), K160524 (d5), K142323 (d5), K102991 (d5), K072786 (d6), K072164 (d6), K083001 (d6), K100830 (d6), K093563 (d6), K103583 (d6), K103677 (d6), K113647 (d6), K053610 (d6), K072285 (d6), K040227 (d6), K042293 (d6), K090196 (d6), K090197 (d6), K121138 (d6), K121329 (d6), K040762 (d6), K081518 (d6), K042540 (d6), K070792 (d6), K120525 (d6), K130499 (d6), K108114 (d6), K123254 (d6), K101236 (d6), K120201 (d6), K123503 (d6), K130695 (d6), K131527 (d6), K100931 (d6), K103152 (d6), K123828 (d6), K120699 (d6), K130058 (d6), K120741 (d6), K051308 (d6), K052805 (d6), K060827 (d6), K081794 (d6), K091009 (d6), K110688 (d6), K111032 (d6), K111302 (d6), K132231 (d6), K132466 (d6), K140677 (d6), K123564 (d6), K132274 (d6), K121063 (d6), K131514 (d6), K141093 (d6), K130739 (d6), K132861 (d6), K133329 (d6), K141620 (d6), K120703 (d6), K141641 (d6), K112339 (d6), K133505 (d6), K142466 (d6), K143264 (d6), K021966 (d6), K130803 (d6), K131164 (d6), K141261 (d6), K143452 (d6), K133431 (d6), K142443 (d6), K103397 (d6), K133034 (d6), K141067 (d6), K141768 (d6), K150949 (d6), K023877 (d7), K030455 (d7), K072797 (d7), K051837 (d7), K061682 (d7), K092159 (d7), K093714 (d7), K093849 (d7), K032974 (d7), K050240 (d7), K052410 (d7), K060542 (d7), K060993 (d7), K101041 (d7), K053069 (d7), K072365 (d7), K091374 (d7), K092271 (d7), K090107 (d7), K091763 (d7), K050326 (d7), K101605 (d7), K063085 (d7), K101757 (d7), K112596 (d7), K102388 (d7), K073709 (d7), K082326 (d7), K101091 (d7), K053435 (d7), K103649 (d7), K071985 (d7), K082374 (d7), K092079 (d7), K022567 (d7), K032114 (d7), K033650 (d7), K042593 (d7), K063803 (d7), K071234 (d7), K081148 (d7), K082142 (d7), K090334 (d7), K093812 (d7), K111674 (d7), K102041 (d7), K081154 (d7), K100919 (d7), K122010 (d7), K111582 (d7), K122921 (d7), K093395 (d7), K110207 (d7), K112255 (d7), K122825 (d7), K031663 (d7), K120221 (d7), K122583 (d7), K130903 (d7), K101455 (d7), K121384 (d7), K060907 (d7), K101874 (d7), K050846 (d7), K031066 (d7), K123185 (d7), K130703 (d7), K131267 (d7), K092619 (d7), K132942 (d7), K132228 (d7), K123806 (d7), K142517 (d7), K070813 (d8), K043524 (d8), K022858 (d8), K062247 (d8), K020789 (d8), K060087 (d8), K094623 (d8), K083882 (d8), K092058 (d8), K043559 (d8), K071134 (d8), K082098 (d8), K073297 (d8), K091970 (d8), K033139 (d8), K041916 (d8), K043196 (d8), K992631 (d8), K090912 (d8), K090855 (d8), K100402 (d8), K123209 (d8), K133761 (d8) — cited as predicate by K241432, K250228

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

Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
  • VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations