# K072932: Infraredix Nir Imaging System, Gen. 1.0, Model MC-5

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Apr 25, 2008 after 192 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
Longest line of descent: 5 generations back to K934139 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052908: Intraredx Nir Imaging System, Model MC-5, Infraredx, Inc. (2006) Summary page 1.
- K980851: Galaxy Intravascular Ultrasound System, Model I5028, Boston Scientific Corp (1998) Summary page 1.
- K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014, Boston Scientific Corp (2005) Summary page 1.
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001, Volcano Corporation (2005) Summary page 1.
- K042188: Volcano Therapeutics, Inc. Volcano Ivus System, Volcano Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K093993: Lipiscan Ivus Imaging System Model Nirs-MC7-70 (2010), 0 descendants of its own

## Indications for use
The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

Source page: https://510kreport.com/device/K072932
Methodology: https://510kreport.com/methodology