FDA AI Clearance Tracker/K252558
Radiology · 510(k)
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
- Device
- Lumify Diagnostic Ultrasound System
- Company
- Philips Ultrasound, LLC
- Submission number
- K252558
- Pathway
- 510(k)
- Decision date
- May 5, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- IYN
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.