FDA AI Clearance Tracker/K260680
Radiology · 510(k)
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
- Device
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- Company
- Philips Ultrasound, LLC
- Submission number
- K260680
- Pathway
- 510(k)
- Decision date
- May 27, 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.