FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
K Number: K213303
·
Decision Dec 7, 2021
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
- K Number
- K213303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infraredx, Inc.
- Date Received
- October 4, 2021
- Decision Date
- December 7, 2021
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Infraredx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Substantially Equivalent |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Apr 12, 2019 | Substantially Equivalent |
| K163345 | TVC Imaging System, TVC Catheter | Jun 21, 2017 | Substantially Equivalent |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Nov 24, 2014 | Substantially Equivalent |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Apr 23, 2014 | Substantially Equivalent |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Oct 17, 2013 | Substantially Equivalent |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Mar 15, 2013 | Substantially Equivalent |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Jun 30, 2010 | Substantially Equivalent |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Apr 25, 2008 | Substantially Equivalent |
| K052908 | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | Jun 23, 2006 | Substantially Equivalent |