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FDA 510(k)

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70

K-Number: K093993 · 2010-06-30

ApplicantInfraredx, Inc.
Decision Date2010-06-30
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K093993. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70?

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Infraredx, Inc.. The 510(k) number is K093993.

When did LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 receive FDA 510(k) clearance?

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 received FDA 510(k) clearance on 2010-06-30, under 510(k) number K093993.

Who is the listed applicant for LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70?

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 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70?

The FDA product code for LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 is OGZ.

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Other records listing Infraredx, Inc. as applicant

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.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterK163345TVC Imaging System, TVC CatheterK130719TVC IMAGING SYSTEM, TVC INSIGHT CATHETERK123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70

View all 9 devices →

Related Devices (Code: OGZ)

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.

K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )Infraredx, Inc.K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterInfraredx, Inc.K163345TVC Imaging System, TVC CatheterInfraredx, Inc.K130719TVC IMAGING SYSTEM, TVC INSIGHT CATHETERInfraredx, Inc.K123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70Infraredx, Inc.K072932INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5Infraredx, Inc.

Official Source

View on FDA Database →

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

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