510(k) K201012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
| Applicant | Philips Ultrasound, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, May 1, 2020 |
| Received | Apr 17, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | Philips Ultrasound, Inc C5-2 Lumify Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc L12-4 Lumify Transducer Probe Open, Classified |
IYN | None listed |
| Aug 22, 2025 | Philips Ultrasound, Inc S4-1 Lumify Transducer Probe Open, Classified |
IYN | None listed |
| Aug 19, 2021 | Philips Ultrasound Inc Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, Terminated |
IYN | None listed |
| Aug 19, 2021 | Philips Ultrasound Inc Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.