K253181
- 510(k) number
- K253181
- Device name
- SURGIMAGE SIM 1000H Fluorescence Imaging Platform
- Applicant
- Surgimage Corporation TW
- Product code
- IZI — System, X-Ray, Angiographic
- Decision date
- 2026-05-13
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253181.pdf
Official FDA record: K253181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.