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

Name: FDA 510(k) clearance K072932
Creator: U.S. Food and Drug Administration
Published: 2008-04-25

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K072932 for INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5, Substantially Equivalent on 2008-04-25. Applicant: Infraredx, Inc.. Device class: 2.

Clearance details

Applicant: Infraredx, Inc.
Product code: Code OGZ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2007-10-16
Decision date: 2008-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OGZ

view all

K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i) +2 more2025-02-26
K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter2019-04-12
K163345 — TVC Imaging System, TVC Catheter2017-06-21
K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER2014-11-24
K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER2014-04-23

More clearances from Infraredx, Inc.

view all

K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-422021-12-07
K130719 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER2013-10-17
K123108 — TVC IMAGING SYSTEM MODEL NIRS-MC7-702013-03-15
K093993 — LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-702010-06-30
K052908 — INTRAREDX NIR IMAGING SYSTEM, MODEL MC-52006-06-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.