# K141682: TVC Imaging System, TVC Insight Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Nov 24, 2014 after 154 days
- Product code: OGZ (Catheter, Intravascular, Plaque Morphology Evaluation)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K163345: TVC Imaging System, TVC Catheter (2017), 0 descendants of its own

## Recalls of this device
- Dec 15, 2016 · Class II · Z-0940-2017: Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of l

## 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/K141682
Methodology: https://510kreport.com/methodology