# K052908: Intraredx Nir Imaging System, Model MC-5

- Pathway: 510(k) (Traditional)
- Applicant: Infraredx, Inc.
- Decided: Jun 23, 2006 after 252 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boston Scientific Galaxy IVUS System: named in the summary without a submission number
- (no number) Boston Scientific Atlantis SR, SR Pro and SR Plus IVUS catheter: named in the summary without a submission number
- (no number) Volcano Revolution and Eagle Eye Gold IVUS catheter, IVUS system: named in the summary without a submission number
- (no number) Baxter Imagecath Coronary Angioscope: named in the summary without a submission number
- (no number) American Edwards Angioscopy catheter/system: named in the summary without a submission number
- (no number) Cardio-Optics CSA System: named in the summary without a submission number

## Most influential descendants
- K072932: Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 (2008), 1 descendant of its own
- K093510: Lumenvu Catheter Guidance System (2010), 0 descendants of its own
- K093993: Lipiscan Ivus Imaging System Model Nirs-MC7-70 (2010), 0 descendants of its own

## Indications for use
The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.

Source page: https://510kreport.com/device/K052908
Methodology: https://510kreport.com/methodology