# K961207: EP-X Biplane

- Pathway: 510(k) (Traditional)
- Applicant: Fischer Imaging Corp.
- Decided: Aug 20, 1996 after 146 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 28, 2005 · Not classified · Z-1524-05: Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
- Apr 28, 2005 · Not classified · Z-1526-05: Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
- Apr 28, 2005 · Not classified · Z-1525-05: Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.

Source page: https://510kreport.com/device/K961207
Methodology: https://510kreport.com/methodology