Philips Ultrasound, LLC is one of 5511 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 Series Diagnostic Ultrasound System, EPIQ Series Diagnostic Ultrasound Systems, Lumify Diagnostic Ultrasound System
23
Total
23
Cleared
0
Denied
Philips Ultrasound, LLC has 23 FDA 510(k) cleared radiology devices. Based in Bothell, US.
Latest FDA clearance: May 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
23 devices
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
Cleared
May 09, 2025
EPIQ Series Diagnostic Ultrasound Systems
Radiology
28d
Cleared
Apr 28, 2025
Flash Ultrasound System 5100 Point of Care
Radiology
112d
Cleared
Apr 10, 2025
EPIQ Series Diagnostic Ultrasound System
Radiology
78d