FDA AI Clearance Tracker/K260844
Radiology · 510(k)
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
- Device
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
- Company
- Siemens Medical Solutions USA, Inc.
- Submission number
- K260844
- Pathway
- 510(k)
- Decision date
- Jun 16, 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.