SURGIMAGE SIM 1000H Fluorescence Imaging Platform— 510(k) K253181

Name: FDA 510(k) clearance K253181
Creator: U.S. Food and Drug Administration
Published: 2026-05-13

Substantially Equivalent

Surgimage Corporation

FDA 510(k) clearance K253181 for SURGIMAGE SIM 1000H Fluorescence Imaging Platform, Substantially Equivalent on 2026-05-13. Applicant: Surgimage Corporation. Device class: 2.

Summary

Surgimage's SURGIMAGE SIM 1000H Fluorescence Imaging Platform is filed under IZI, angiographic x-ray systems.

Class II, 21 CFR 892.1600. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Radiology as the classification panel.

Surgimage filed from Taipei City, Taiwan. The decision came 229 calendar days after receipt (September 26, 2025 to May 13, 2026).

Clearance details

Applicant: Surgimage Corporation
Product code: Product code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 2025-09-26
Decision date: 2026-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.