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Philips Ultrasound, LLC

FDA 510(k) & PMA Approved Devices — 26 products

Total Devices26
Categories3
Latest FDA decision2026-08-04
TypeNumberDevice NameCodeDateActions
510(k) K262311 Alturion Series Diagnostic Ultrasound SystemIYN2026-08-04 View
510(k) K261211 Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemIYN2026-07-27 View
510(k) K260667 Alturion Series Diagnostic Ultrasound SystemIYN2026-06-29 View
510(k) K260123 EPIQ Series Diagnostic Ultrasound SystemIYN2026-05-27 View
510(k) K260680 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2026-05-27 View
510(k) K252558 Lumify Diagnostic Ultrasound SystemIYN2026-05-05 View
510(k) K253595 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2026-03-27 View
510(k) K252557 Lumify Diagnostic Ultrasound SystemIYN2025-12-22 View
510(k) K251651 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-10-09 View
510(k) K251455 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-07-24 View
510(k) K250886 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-06-18 View
510(k) K243793 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-05-21 View
510(k) K251110 EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN2025-05-09 View
510(k) K250030 Flash Ultrasound System 5100 Point of CareIYN2025-04-28 View
510(k) K250177 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-04-10 View
510(k) K241659 Ultrasound Workspace (UWS 6.0)QIH2025-02-10 View
510(k) K243794 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2025-02-06 View
510(k) K242020 EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN2024-12-12 View
510(k) K242800 The 5000 Compact Series Ultrasound SystemsIYN2024-11-15 View
510(k) K240980 EPIQ Series Diagnostic Ultrasound SystemIYN2024-10-07 View

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