# K024085: CCD Camera, Model PKP-06000-000

- Pathway: 510(k) (Traditional)
- Applicant: Perkins Electronics Co.
- Decided: Mar 11, 2003 after 90 days
- Product code: IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot)
- Device class: 2
- Regulation: 21 CFR 892.1620
- 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
This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.

Source page: https://510kreport.com/device/K024085
Methodology: https://510kreport.com/methodology