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Philips Ultrasound, LLC FDA Approvals

0 new drug approvals and 27 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Sep 25, 2026Radiology
Alturion Series Diagnostic Ultrasound System510(k)Aug 4, 2026Radiology
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System510(k)Jul 27, 2026Radiology
Alturion Series Diagnostic Ultrasound System510(k)Jun 29, 2026Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems510(k)May 27, 2026Radiology
EPIQ Series Diagnostic Ultrasound System510(k)May 27, 2026Radiology
Lumify Diagnostic Ultrasound System510(k)May 5, 2026Radiology
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System510(k)Mar 27, 2026Radiology
Lumify Diagnostic Ultrasound System510(k)Dec 22, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Oct 9, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Jul 24, 2025Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems510(k)Jun 18, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)May 21, 2025Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems510(k)May 9, 2025Radiology
Flash Ultrasound System 5100 Point of Care510(k)Apr 28, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Apr 10, 2025Radiology
Ultrasound Workspace (UWS 6.0)510(k)Feb 10, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Feb 6, 2025Radiology
EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Dec 12, 2024Radiology
The 5000 Compact Series Ultrasound Systems510(k)Nov 15, 2024Radiology
EPIQ Series Diagnostic Ultrasound System510(k)Oct 7, 2024Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems510(k)Apr 24, 2024Radiology
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System510(k)Feb 13, 2024Radiology
EPIQ Series Diagnostic Ultrasound System510(k)Nov 30, 2023Radiology
EPIQ Series Diagnostic Ultrasound System510(k)May 12, 2023Radiology
PercuNav Image Fusion and Interventional Navigation System510(k)Jan 18, 2023Radiology
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)510(k)Sep 27, 2022Radiology

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