# K030061: PS 3000 Digatal Photospot System

- Pathway: 510(k) (Traditional)
- Applicant: Precise Optics
- Decided: Apr 7, 2003 after 90 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K963037 (1996). 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)
- K963037: Patriot, Infimed, Inc. (1996) Summary page 2.

## Indications for use
The PS 3000 Digital PhotoSpot System ™ is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed. The PS 3000 Digital PhotoSpot System ™ is indicated for use when it is necessary for a trained health care professional (for example an Radiologist) to acquire, record, review and distribute a digital image from a x-ray image intensifiers in diagnostic imaging chains, The PS 3000 Digital PhotoSpot System ™ is a prescription device. The labeling, instructions and user operations are designed for trained professionals.

Source page: https://510kreport.com/device/K030061
Methodology: https://510kreport.com/methodology