Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i) +2 more— 510(k) K241576
Substantially EquivalentInfraredx, Inc.
FDA 510(k) clearance K241576 for Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i) +2 more, Substantially Equivalent on 2025-02-26. Applicant: Infraredx, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
- Applicant
- Infraredx, Inc.
- Product code
- Code OGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code OGZ
view allMore 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-E195-42
- K123108 — TVC IMAGING SYSTEM MODEL NIRS-MC7-70
- K093993 — LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
- K072932 — INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
- K052908 — INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
Data sourced from openFDA. This site is unofficial and independent of the FDA.