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.

Clearance details

Applicant: Surgimage Corporation
Product code: 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 ↗

Recent devices under product code IZI

view all

K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
K243645 — IC-Flow Imaging System 2.02025-09-22
K243077 — Affirm 8002025-06-27
K231986 — Modus IR2024-03-25
K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)2024-03-20

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.