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INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 — Infraredx, Inc. (510(k) K072932)

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 — Infraredx, Inc. (510(k) K072932) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5; Applicant: Infraredx, Inc.; Clearance track: 510(k).

Device nameINFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
ApplicantInfraredx, Inc.
Clearance track510(k)
Submission numberK072932
DecisionSubstantially Equivalent
Decision date2008-04-25
Date received2007-10-16
Product codeOGZ
Device class2
Medical specialtyCardiovascular
Applicant locationMA, US
SourceopenFDA device

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