# K062340: Cardiooptics Augmentative Cardiac Optical Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Cardio-Optics, Inc.
- Decided: Nov 30, 2006 after 112 days
- Product code: LYK (Angioscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K893658 (1989). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050808: Coronary Sinus Access Kit, Model KCS8F-01, Cardio-Optics, Inc. (2005) Summary page 1.
- K911278: Olympus AF Angioscope System, Olympus Corp. (1991) Summary page 1.
- K860858: Olympus PF-18 & PF-25 Ultrathin Angioscope, Olympus Corp. (1986) Summary page 1.
- K042593: Acuson Acunav 8F Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K031066: Viewmate Ultrasound Imaging System, Ep Medsystems (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K011763: Omnidos, Scanditronix Medical AB (2001). Our reading of the summary gave K011763, FDA’s number for Omnidos (Scanditronix Medical AB). Its FDA name has none of the distinctive words the summary uses for the device it names, “FSEA Fiberscope”. Kept off the family tree. Summary page 1.

## Indications for use
The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image anatomical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging. The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

Source page: https://510kreport.com/device/K062340
Methodology: https://510kreport.com/methodology