# K972520: Optiview

- Pathway: 510(k) (Traditional)
- Applicant: Optimed Technologies, Inc.
- Decided: Sep 29, 1997 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
OptiView is a digital image recording and display system for use in a cardiac cath lab or radiography/fluoroscopy suite. It is a digital upgrade for the cardiac catheterization lab. I'interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in produciivity. Integrated with the room’s x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.

Source page: https://510kreport.com/device/K972520
Methodology: https://510kreport.com/methodology