Philips Ultrasound, LLC is one of 16090 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Philips Ultrasound, LLC - FDA 510(k) Cleared Devices
Recent clearances: EPIQ Inspira Series Diagnostic Ultrasound System, Alturion Series Diagnostic Ultrasound System, Philips EPIQ Series Diagnostic Ultrasound System
26
Total
26
Cleared
0
Denied
Philips Ultrasound, LLC has 26 FDA 510(k) cleared radiology devices. Based in Bothell, US.
Latest FDA clearance: Sep 2026. Active since 2022.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Philips Ultrasound, LLC
26 devices
Cleared
Sep 25, 2026
EPIQ Inspira Series Diagnostic Ultrasound System
Radiology
64d
Cleared
Aug 04, 2026
Alturion Series Diagnostic Ultrasound System
Radiology
27d
Cleared
Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
Radiology
104d
Cleared
May 27, 2026
EPIQ Series Diagnostic Ultrasound System
Radiology
132d
Cleared
May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems
Radiology
86d
Cleared
May 05, 2026
Lumify Diagnostic Ultrasound System
Radiology
265d
Cleared
Mar 27, 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
Radiology
129d
Cleared
Dec 22, 2025
Lumify Diagnostic Ultrasound System
Radiology
131d
Cleared
Oct 09, 2025
EPIQ Series Diagnostic Ultrasound System
Radiology
133d
Cleared
Jul 24, 2025
EPIQ Series Diagnostic Ultrasound System
Radiology
73d
Cleared
Jun 18, 2025
EPIQ Series Diagnostic Ultrasound Systems
Radiology
85d
Cleared
May 21, 2025
EPIQ Series Diagnostic Ultrasound System
Radiology
162d