K251763
- 510(k) number
- K251763
- Device name
- IRISeg
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-12-16
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251763.pdf
Official FDA record: K251763
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.