Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TVC IMAGING SYSTEM MODEL NIRS-MC7-70

K-Number: K123108 · 2013-03-15

ApplicantInfraredx, Inc.
Decision Date2013-03-15
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TVC 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 2013-03-15 under 510(k) number K123108. 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 TVC IMAGING SYSTEM MODEL NIRS-MC7-70?

TVC IMAGING SYSTEM MODEL NIRS-MC7-70 is a medical device that received FDA 510(k) clearance on 2013-03-15. The listed applicant is Infraredx, Inc.. The 510(k) number is K123108.

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

TVC IMAGING SYSTEM MODEL NIRS-MC7-70 received FDA 510(k) clearance on 2013-03-15, under 510(k) number K123108.

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CATHETERK093993LIPISCAN IVUS 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.K093993LIPISCAN IVUS 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.

↑