SURGIMAGE SIM 1000H Fluorescence Imaging Platform
K-Number: K253181 · 2026-05-13
ApplicantSurgimage Corporation
Decision Date2026-05-13
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SURGIMAGE SIM 1000H Fluorescence Imaging Platform is a medical device manufactured by Surgimage Corporation. It received FDA 510(k) clearance on 2026-05-13 under approval number K253181. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform is a medical device that received FDA 510(k) clearance on 2026-05-13. It is manufactured by Surgimage Corporation. The 510(k) number is K253181.
When was SURGIMAGE SIM 1000H Fluorescence Imaging Platform approved by the FDA?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform received FDA 510(k) clearance on 2026-05-13, under approval number K253181.
What company makes SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform is manufactured by Surgimage Corporation.
What is the FDA product code for SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
The FDA product code for SURGIMAGE SIM 1000H Fluorescence Imaging Platform is IZI.
Related PubMed Literature
Official Source
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