# K970525: Statnet

- Pathway: 510(k) (Traditional)
- Applicant: Gorca Systems, Inc.
- Decided: Apr 16, 1997 after 64 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- 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 K934496 (1993). 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)
- K934496: X-Ray Angiographic System, Camtronics, Ltd. (1993) Summary page 1.
- (no number) IMACS: named in the summary without a submission number
- (no number) EIGEN: named in the summary without a submission number

## Indications for use
StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.

Source page: https://510kreport.com/device/K970525
Methodology: https://510kreport.com/methodology