510(k) K123108
- Device
- TVC IMAGING SYSTEM MODEL NIRS-MC7-70
- Applicant
- Infraredx, Inc.
- 510(k) number
- K123108
- Product code
- OGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-15
- Date received
- 2012-10-03
- Regulation
- 870.1200
- Classification name
- Catheter, Intravascular, Plaque Morphology Evaluation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN J CHARTIER
- Address
- 34 Third Ave. Burlington MA US 01803 01803
FDA Registration Numbers#
- 3017654247
- 1061124
- 1220477
- 2245304
- 8043817
- 3015551113
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | Infraredx, Inc. | 2025-02-26 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Infraredx, Inc. | 2019-04-12 |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | 2017-06-21 |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-11-24 |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-04-23 |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2013-10-17 |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2010-06-30 |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | 2008-04-25 |
Legacy Summary#
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FDA Review#
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