# K060175: Isight Imaging Catheter, Model 38986

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 24, 2006 after 60 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
Longest line of descent: 1 generation back to K050577 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050577: Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014, Boston Scientific Corp (2005) Summary page 2.

## Indications for use
The iSight TM Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Source page: https://510kreport.com/device/K060175
Methodology: https://510kreport.com/methodology