FDA 510(k)

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5

K-Number: K052908 · 2006-06-23

Decision Date2006-06-23

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K052908. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5?

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Infraredx, Inc.. The 510(k) number is K052908.

When did INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 receive FDA 510(k) clearance?

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 received FDA 510(k) clearance on 2006-06-23, under 510(k) number K052908.

Who is the listed applicant for INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5?

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

What is the FDA product code for INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5?

The FDA product code for INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 is DQO.

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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.