# Infraredx, Inc.

- Location (FDA's records): Burlington, MA
- FDA decisions: 11 (2006–2025): 11 510(k) clearances
- Product codes: OGZ (9), DQO (1), IYO (1)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)
- Volcano Therapeutics, Inc.: 1 (https://510kreport.com/company/volcano-therapeutics)

## Firms that cite its devices most
- Sonosite,Inc.: 1 (https://510kreport.com/company/sonosite)
- Spectrawave, Inc.: 1 (https://510kreport.com/company/spectrawave)

## Its most-cited devices
- K052908: Intraredx Nir Imaging System, Model MC-5 (2006), cited by 2
- K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (2019), cited by 2
- K072932: Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 (2008), cited by 1
- K141682: TVC Imaging System, TVC Insight Catheter (2014), cited by 1
- K213303: Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (2021), cited by 1

## Recent decisions
- K241576: Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) (Feb 26, 2025)
- K213303: Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 (Dec 7, 2021)
- K183599: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (Apr 12, 2019)
- K163345: TVC Imaging System, TVC Catheter (Jun 21, 2017)
- K141682: TVC Imaging System, TVC Insight Catheter (Nov 24, 2014)
- K133897: TVC Imaging System, TVC Insight Catheter (Apr 23, 2014)
- K130719: TVC Imaging System, TVC Insight Catheter (Oct 17, 2013)
- K123108: TVC Imaging System Model Nirs-MC7-70 (Mar 15, 2013)

Source page: https://510kreport.com/company/infraredx