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Phased array probe

Model P2-T · CHISON Medical Technologies Co., Ltd. · DI 06945121413299

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

UDILibrary device dossier · generated 2026-09-14 · 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.

4812172019-01: 0 reports for this device; peer average 2.65/device2019-02: 0 reports for this device; peer average 4.85/device2019-03: 0 reports for this device; peer average 4.67/device2019-04: 0 reports for this device; peer average 3.17/device2019-05: 0 reports for this device; peer average 4.17/device2019-06: 0 reports for this device; peer average 5.17/device2019-07: 0 reports for this device; peer average 4.81/device2019-08: 0 reports for this device; peer average 5.87/device2019-09: 0 reports for this device; peer average 2.97/device2019-10: 0 reports for this device; peer average 3.17/device2019-11: 0 reports for this device; peer average 3.54/device2019-12: 0 reports for this device; peer average 4.79/device2020-01: 0 reports for this device; peer average 2.53/device2020-02: 0 reports for this device; peer average 3.88/device2020-03: 0 reports for this device; peer average 4.8/device2020-04: 0 reports for this device; peer average 4.04/device2020-05: 0 reports for this device; peer average 2.48/device2020-06: 0 reports for this device; peer average 3.1/device2020-07: 0 reports for this device; peer average 4.05/device2020-08: 0 reports for this device; peer average 2.73/device2020-09: 0 reports for this device; peer average 1.97/device2020-10: 0 reports for this device; peer average 3.78/device2020-11: 0 reports for this device; peer average 3.47/device2020-12: 0 reports for this device; peer average 4.78/device2021-01: 0 reports for this device; peer average 5.15/device2021-02: 0 reports for this device; peer average 4.14/device2021-03: 0 reports for this device; peer average 5.71/device2021-04: 0 reports for this device; peer average 3.63/device2021-05: 0 reports for this device; peer average 5/device2021-06: 0 reports for this device; peer average 4.98/device2021-07: 0 reports for this device; peer average 6.52/device2021-08: 0 reports for this device; peer average 5.93/device2021-09: 0 reports for this device; peer average 7.41/device2021-10: 0 reports for this device; peer average 5.72/device2021-11: 0 reports for this device; peer average 5.41/device2021-12: 0 reports for this device; peer average 7.97/device2022-01: 0 reports for this device; peer average 5.5/device2022-02: 0 reports for this device; peer average 7.74/device2022-03: 0 reports for this device; peer average 6.18/device2022-04: 0 reports for this device; peer average 6.57/device2022-05: 0 reports for this device; peer average 7.45/device2022-06: 0 reports for this device; peer average 6.17/device2022-07: 0 reports for this device; peer average 5.91/device2022-08: 0 reports for this device; peer average 5.09/device2022-09: 0 reports for this device; peer average 4.74/device2022-10: 0 reports for this device; peer average 4.43/device2022-11: 0 reports for this device; peer average 4.38/device2022-12: 0 reports for this device; peer average 4.81/device2023-01: 0 reports for this device; peer average 5.11/device2023-02: 0 reports for this device; peer average 4.55/device2023-03: 0 reports for this device; peer average 4.97/device2023-04: 0 reports for this device; peer average 3.69/device2023-05: 0 reports for this device; peer average 5.94/device2023-06: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 4.12/device2023-08: 0 reports for this device; peer average 5.33/device2023-09: 0 reports for this device; peer average 5.39/device2023-10: 0 reports for this device; peer average 6.24/device2023-11: 0 reports for this device; peer average 4.53/device2023-12: 0 reports for this device; peer average 4.9/device2024-01: 0 reports for this device; peer average 5.69/device2024-02: 0 reports for this device; peer average 4.3/device2024-03: 0 reports for this device; peer average 5.32/device2024-04: 0 reports for this device; peer average 5.47/device2024-05: 0 reports for this device; peer average 4.08/device2024-06: 0 reports for this device; peer average 5.54/device2024-07: 0 reports for this device; peer average 4.78/device2024-08: 0 reports for this device; peer average 5.3/device2024-09: 0 reports for this device; peer average 5.27/device2024-10: 0 reports for this device; peer average 5.75/device2024-11: 0 reports for this device; peer average 3.89/device2024-12: 0 reports for this device; peer average 9.38/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 3.85/device2025-03: 0 reports for this device; peer average 6.11/device2025-04: 0 reports for this device; peer average 3.21/device2025-05: 0 reports for this device; peer average 4.2/device2025-06: 0 reports for this device; peer average 4.15/device2025-07: 0 reports for this device; peer average 4.17/device2025-08: 0 reports for this device; peer average 5.65/device2025-09: 0 reports for this device; peer average 6.56/device2025-10: 0 reports for this device; peer average 9.4/device2025-11: 0 reports for this device; peer average 11.48/device2025-12: 0 reports for this device; peer average 16.54/device2026-01: 0 reports for this device; peer average 10.77/device2026-02: 0 reports for this device; peer average 6.4/device2026-03: 0 reports for this device; peer average 8.18/device2026-04: 0 reports for this device; peer average 10.63/device2026-05: 0 reports for this device; peer average 15.69/device2026-06: 0 reports for this device; peer average 14.42/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.65
2019-0204.85
2019-0304.67
2019-0403.17
2019-0504.17
2019-0605.17
2019-0704.81
2019-0805.87
2019-0902.97
2019-1003.17
2019-1103.54
2019-1204.79
2020-0102.53
2020-0203.88
2020-0304.8
2020-0404.04
2020-0502.48
2020-0603.1
2020-0704.05
2020-0802.73
2020-0901.97
2020-1003.78
2020-1103.47
2020-1204.78
2021-0105.15
2021-0204.14
2021-0305.71
2021-0403.63
2021-0505
2021-0604.98
2021-0706.52
2021-0805.93
2021-0907.41
2021-1005.72
2021-1105.41
2021-1207.97
2022-0105.5
2022-0207.74
2022-0306.18
2022-0406.57
2022-0507.45
2022-0606.17
2022-0705.91
2022-0805.09
2022-0904.74
2022-1004.43
2022-1104.38
2022-1204.81
2023-0105.11
2023-0204.55
2023-0304.97
2023-0403.69
2023-0505.94
2023-0604
2023-0704.12
2023-0805.33
2023-0905.39
2023-1006.24
2023-1104.53
2023-1204.9
2024-0105.69
2024-0204.3
2024-0305.32
2024-0405.47
2024-0504.08
2024-0605.54
2024-0704.78
2024-0805.3
2024-0905.27
2024-1005.75
2024-1103.89
2024-1209.38
2025-0104
2025-0203.85
2025-0306.11
2025-0403.21
2025-0504.2
2025-0604.15
2025-0704.17
2025-0805.65
2025-0906.56
2025-1009.4
2025-11011.48
2025-12016.54
2026-01010.77
2026-0206.4
2026-0308.18
2026-04010.63
2026-05015.69
2026-06014.42
This device (reports/month)Average device in ITX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K200780 — cites (transitively): K141846 (d1), K171233 (d1), K180974 (d1), K112596 (d2), K121699 (d2), K123001 (d2), K132804 (d2), K081386 (d2), K151175 (d2), K152763 (d2), K153277 (d2), K153529 (d2), K162267 (d2), K162269 (d2), K163077 (d2), K170277 (d2), K150861 (d2), K170374 (d2), K033650 (d3), K042593 (d3), K063085 (d3), K071234 (d3), K072786 (d3), K081148 (d3), K082142 (d3), K090334 (d3), K093812 (d3), K992631 (d3), K014206 (d3), K080760 (d3), K090276 (d3), K093531 (d3), K101091 (d3), K102997 (d3), K093612 (d3), K111674 (d3), K116174 (d3), K121138 (d3), K123622 (d3), K130619 (d3), K130739 (d3), K132341 (d3), K150249 (d3), K132335 (d3), K132913 (d3), K141010 (d3), K142160 (d3), K150080 (d3), K150204 (d3), K061961 (d3), K093466 (d3), K133905 (d3), K134016 (d3), K142008 (d3), K113758 (d3), K122327 (d3), K143089 (d3), K150478 (d3), K151663 (d3), K152962 (d3), K152309 (d3), K152567 (d3), K131690 (d3), K152543 (d3), K160807 (d3), K153085 (d3), K063518 (d4), K082430 (d4), K063803 (d4), K022858 (d4), K053069 (d4), K062247 (d4), K073709 (d4), K082326 (d4), K080935 (d4), K083095 (d4), K093462 (d4), K022567 (d4), K032114 (d4), K070242 (d4), K072365 (d4), K102017 (d4), K113179 (d4), K122825 (d4), K122826 (d4), K121010 (d4), K108114 (d4), K123254 (d4), K101236 (d4), K120201 (d4), K100931 (d4), K103152 (d4), K123828 (d4), K130308 (d4), K051308 (d4), K052805 (d4), K060827 (d4), K081794 (d4), K091009 (d4), K110688 (d4), K111032 (d4), K111302 (d4), K132231 (d4), K132466 (d4), K140677 (d4), K123564 (d4), K132274 (d4), K132861 (d4), K133329 (d4), K141620 (d4), K132779 (d4), K120703 (d4), K141641 (d4), K112339 (d4), K133505 (d4), K142466 (d4), K143264 (d4), K021966 (d4), K130803 (d4), K130881 (d4), K131164 (d4), K131514 (d4), K131527 (d4), K121062 (d4), K143472 (d4), K142472 (d4), K103397 (d4), K043535 (d4), K081661 (d4), K120321 (d4), K121498 (d4), K130159 (d4), K132165 (d4), K132304 (d4), K051837 (d5), K061682 (d5), K001400 (d5), K051139 (d5), K092159 (d5), K093714 (d5), K093849 (d5), K090107 (d5), K091763 (d5), K050326 (d5), K101605 (d5), K102388 (d5), K093563 (d5), K103583 (d5), K103677 (d5), K113647 (d5), K053610 (d5), K080891 (d5), K081154 (d5), K100919 (d5), K092271 (d5), K111582 (d5), K122921 (d5), K093395 (d5), K110207 (d5), K040227 (d5), K042293 (d5), K102901 (d5), K121329 (d5), K112255 (d5), K031663 (d5), K120221 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K130499 (d5), K113690 (d5), K123503 (d5), K130695 (d5), K122583 (d5), K130903 (d5), K101455 (d5), K121384 (d5), K050846 (d5), K031066 (d5), K123185 (d5), K130703 (d5), K132228 (d5), K131609 (d5), K023877 (d6), K030455 (d6), K070813 (d6), K043524 (d6), K020789 (d6), K060087 (d6), K094623 (d6), K083882 (d6), K092058 (d6), K033139 (d6), K092079 (d6), K032974 (d6), K050240 (d6), K052410 (d6), K060542 (d6), K060993 (d6), K101041 (d6), K091374 (d6), K041916 (d6), K043196 (d6), K091970 (d6), K102041 (d6), K101757 (d6), K120699 (d6), K122010 (d6), K090855 (d6), K040762 (d6), K043559 (d7), K071134 (d7), K082098 (d7), K083001 (d7), K090912 (d7), K100830 (d7), K102991 (d7), K072797 (d8), K072164 (d8) — cited as predicate by K223570, K233697

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

Manufacturer compliance record — CHISON Medical Technologies Co., Ltd.

  • VAI 2015-05-14 CHISON Medical Technologies Co., Ltd. · 1 citations
  • VAI 2015-05-14 CHISON Medical Technologies Co., Ltd. · 1 citations
  • NAI 2012-06-14 CHISON Medical Technologies Co., Ltd. · 0 citations
  • NAI 2012-06-14 CHISON Medical Technologies Co., Ltd. · 0 citations