510(k) K182857 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Nov 9, 2018 |
| Received | Oct 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Philips Ultrasound, Inc Philips X7-2 Ultrasound Transducer Open, Classified |
ITX | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc C6-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc eL18-4 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S8-3t Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S9-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc V9-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc VL13-5 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X7-2 Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc X8-2t Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc XL14-3 Transducer Probe Open, Classified |
IYN | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips eL18-4 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips eL18-4 EMT Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips S8-3t Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips VL13-5 Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips X8-2t Transducer. Open, Classified |
ITX | None listed |
| Jul 2, 2025 | Philips Ultrasound, Inc Philips XL14-3 Transducer. Open, Classified |
ITX | None listed |
| Aug 6, 2021 | Philips Ultrasound Inc EPIQ Diagnostic Ultrasound Systems:
Software Versions 5.0, 5.0.1 and 5.0.2
Models:
EPIQ 5 - 795120
EPIQ 5C - 795205
EPIQ 5G - 795204
EPIQ 7 - 795117
EPIQ 7C - 795201
EPIQ 7G - 795200
EPIQ CVxi -7952 Completed |
IYO | None listed |
| Aug 6, 2021 | Philips Ultrasound Inc Affiniti Diagnostic Ultrasound Systems:
Software Versions 5.0, 5.0.1 and 5.0.2
Models:
Affiniti 30 795121
Affiniti 30 795218
Affiniti 50 795208
Affiniti 50 795118
Affiniti 70 795210
Affiniti 70 7951 Completed |
IYO | None listed |
| Jul 22, 2021 | Philips Ultrasound Inc EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi Completed |
IYN | None listed |
| Dec 24, 2020 | Philips Ultrasound Inc Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and Terminated |
IYN | None listed |
| Dec 16, 2020 | Philips Ultrasound Inc Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi.
MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, Terminated |
IYN | None listed |
| Oct 27, 2020 | Philips Ultrasound Inc All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System.
MOD - E Terminated |
IYN | None listed |
| Aug 6, 2019 | Philips Ultrasound Inc Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70.
Product Usage Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.