Medical Device Manufacturer · US , Bothell , WA

Philips Ultrasound, LLC - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2022
20
Total
20
Cleared
0
Denied

Philips Ultrasound, LLC has 20 FDA 510(k) cleared radiology devices. Based in Bothell, US.

Latest FDA clearance: Mar 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
20 devices
1-20 of 20
Cleared Mar 27, 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K253595 · IYN
Radiology · 129d
Cleared Dec 22, 2025
Lumify Diagnostic Ultrasound System
K252557 · IYN
Radiology · 131d
Cleared Oct 09, 2025
EPIQ Series Diagnostic Ultrasound System
K251651 · IYN
Radiology · 133d
Cleared Jul 24, 2025
EPIQ Series Diagnostic Ultrasound System
K251455 · IYN
Radiology · 73d
Cleared Jun 18, 2025
EPIQ Series Diagnostic Ultrasound Systems
K250886 · IYN
Radiology · 85d
Cleared May 21, 2025
EPIQ Series Diagnostic Ultrasound System
K243793 · IYN
Radiology · 162d
Cleared May 09, 2025
EPIQ Series Diagnostic Ultrasound Systems
K251110 · IYN
Radiology · 28d
Cleared Apr 28, 2025
Flash Ultrasound System 5100 Point of Care
K250030 · IYN
Radiology · 112d
Cleared Apr 10, 2025
EPIQ Series Diagnostic Ultrasound System
K250177 · IYN
Radiology · 78d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Radiology · 245d
Cleared Feb 06, 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · IYN
Radiology · 58d
Cleared Dec 12, 2024
EPIQ Series Diagnostic Ultrasound System
K242020 · IYN
Radiology · 154d
Cleared Nov 15, 2024
The 5000 Compact Series Ultrasound Systems
K242800 · IYN
Radiology · 59d
Cleared Oct 07, 2024
EPIQ Series Diagnostic Ultrasound System
K240980 · IYN
Radiology · 180d
Cleared Apr 24, 2024
EPIQ Series Diagnostic Ultrasound Systems
K240850 · IYN
Radiology · 28d
Cleared Feb 13, 2024
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K233788 · IYN
Radiology · 77d
Cleared Nov 30, 2023
EPIQ Series Diagnostic Ultrasound System
K233545 · IYN
Radiology · 27d
Cleared May 12, 2023
EPIQ Series Diagnostic Ultrasound System
K231190 · IYN
Radiology · 16d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Radiology · 30d
Cleared Sep 27, 2022
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound...
K222648 · IYN
Radiology · 26d
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