Clearance Summary
SURGIMAGE SIM 1000H Fluorescence Imaging Platform received FDA 510(k) clearance under submission number K253181, sponsored by Surgimage Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-05-13.
- Submission: K253181
- Applicant / Sponsor: Surgimage Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 2026-05-13
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.