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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Surgimage Corporation. It received FDA 510(k) clearance on 2026-05-13 under 510(k) 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. The listed applicant is Surgimage Corporation. The 510(k) number is K253181.

When did SURGIMAGE SIM 1000H Fluorescence Imaging Platform receive FDA 510(k) clearance?

SURGIMAGE SIM 1000H Fluorescence Imaging Platform received FDA 510(k) clearance on 2026-05-13, under 510(k) number K253181.

Who is the listed applicant for SURGIMAGE SIM 1000H Fluorescence Imaging Platform?

The FDA 510(k) record lists Surgimage Corporation as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbHK231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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