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Infraredx, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241576 Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )OGZ2025-02-26 View
510(k) K213303 Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42IYO2021-12-07 View
510(k) K183599 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZ2019-04-12 View
510(k) K163345 TVC Imaging System, TVC CatheterOGZ2017-06-21 View
510(k) K130719 TVC IMAGING SYSTEM, TVC INSIGHT CATHETEROGZ2013-10-17 View
510(k) K123108 TVC IMAGING SYSTEM MODEL NIRS-MC7-70OGZ2013-03-15 View
510(k) K093993 LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70OGZ2010-06-30 View
510(k) K072932 INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5OGZ2008-04-25 View
510(k) K052908 INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5DQO2006-06-23 View
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