Philips Ultrasound, LLC
Philips Ultrasound, LLC holds FDA 510(k) medical device clearances, first cleared 2022, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Philips Ultrasound, LLC
FDA recalls by Philips Ultrasound, LLC
- Z-0883-2026 — Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
- Z-1007-2026 — Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Ultrasound, LLC
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
- K260667 — Alturion Series Diagnostic Ultrasound System
- K260123 — EPIQ Series Diagnostic Ultrasound System
- K260680 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K252558 — Lumify Diagnostic Ultrasound System
- K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K252557 — Lumify Diagnostic Ultrasound System
- K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K250030 — Flash Ultrasound System 5100 Point of Care
- K250177 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K241659 — Ultrasound Workspace (UWS 6.0)
- K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K242020 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K242800 — The 5000 Compact Series Ultrasound Systems
- K240980 — EPIQ Series Diagnostic Ultrasound System
- K240850 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K233788 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K233545 — EPIQ Series Diagnostic Ultrasound System
- K231190 — EPIQ Series Diagnostic Ultrasound System
- K223804 — PercuNav Image Fusion and Interventional Navigation System
- K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
Data sourced from openFDA. This site is unofficial and independent of the FDA.