# K133897: TVC Imaging System, TVC Insight Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Apr 23, 2014 after 124 days
- Product code: OGZ (Catheter, Intravascular, Plaque Morphology Evaluation)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
1. The TVC Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K133897
Methodology: https://510kreport.com/methodology