Infraredx, Inc.
Medical device manufacturer in Bedford, MA.
11510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging…OGZ · Traditional | 02/26/2025SE |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…IYO · Traditional | 12/07/2021SE |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZ · Traditional | 04/12/2019SE |
| K163345 | TVC Imaging System, TVC CatheterOGZ · Traditional | 06/21/2017SE |
| K141682 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | 11/24/2014SE |
| K133897 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | 04/23/2014SE |
| K130719 | TVC Imaging System, TVC Insight CatheterOGZ · Traditional | 10/17/2013SE |
| K123108 | TVC Imaging System Model NIRS-MC7-70OGZ · Traditional | 03/15/2013SE |
| K093993 | Lipiscan Ivus Imaging System Model NIRS-MC7-70OGZ · Traditional | 06/30/2010SE |
| K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5OGZ · Traditional | 04/25/2008SE |
| K052908 | Intraredx Nir Imaging System, Model MC-5DQO · Traditional | 06/23/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0940-2017 Class II | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary…Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases… | 12/15/2016Terminated |