# K093993: Lipiscan Ivus Imaging System Model Nirs-MC7-70

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Jun 30, 2010 after 188 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: 6 generations back to K934139 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072932: Infraredix Nir Imaging System, Gen. 1.0, Model MC-5, Infraredx, Inc. (2008) Summary page 1.
- K051679: Ilab Ultrasound Imaging System, Boston Scientific Corp (2005) Summary page 1.
- K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014, Boston Scientific Corp (2005) Summary page 1.

## Indications for use
1. The LipiScan TM IVUS 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/K093993
Methodology: https://510kreport.com/methodology