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21 devices · 2 companies · 2023 to 2026

Philips Ultrasound, LLC: AI-enabled devices on FDA's list

21 devices from Philips Ultrasound, LLC, 2023 to 2026, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (21 of 21 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Philips Ultrasound, LLC

Every device, newest decision first

Philips Ultrasound, LLC · 21 devices
DecisionDevicePanelProduct codeFDA
Alturion Series Diagnostic Ultrasound SystemK260667 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK260123 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK260680 · 510(k)RadiologyIYNdatabase entry
Lumify Diagnostic Ultrasound SystemK252558 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound System, AffiniK253595 · 510(k)RadiologyIYNdatabase entry
Lumify Diagnostic Ultrasound SystemK252557 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK251651 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK251455 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK250886 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK243793 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK251110 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK250177 · 510(k)RadiologyIYNdatabase entry
Ultrasound WorkspaceK241659 · 510(k)RadiologyQIHdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK243794 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK242020 · 510(k)RadiologyIYNdatabase entry
The 5000 Compact Series Ultrasound SystemsK242800 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK240980 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK240850 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound System, AffiniK233788 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK233545 · 510(k)RadiologyIYNdatabase entry
EPIQ Series Diagnostic Ultrasound SystemK231190 · 510(k)RadiologyIYNdatabase entry

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