Infraredx, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i), Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42, Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Infraredx, Inc. Cardiovascular ✕
11 devices
Cleared
Feb 26, 2025
Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i)
Cardiovascular
268d
Cleared
Dec 07, 2021
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS...
Cardiovascular
64d
Cleared
CT
Apr 12, 2019
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
Cardiovascular
107d
Cleared
Jun 21, 2017
TVC Imaging System, TVC Catheter
Cardiovascular
204d
Cleared
Nov 24, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Cardiovascular
154d
Cleared
Apr 23, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Cardiovascular
124d
Cleared
Oct 17, 2013
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Cardiovascular
213d
Cleared
Mar 15, 2013
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
Cardiovascular
163d
Cleared
Jun 30, 2010
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
Cardiovascular
188d
Cleared
Apr 25, 2008
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
Cardiovascular
192d
Cleared
Jun 23, 2006
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
Cardiovascular
252d