K251416
- 510(k) number
- K251416
- Device name
- UltraSight Guidance
- Applicant
- Ultrasight , Ltd. IL
- Product code
- QJU — Image Acquisition And/Or Optimization Guided By Arti
- Decision date
- 2025-12-17
- Date received
- 2025-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K251416.pdf
Official FDA record: K251416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.