# K051494: Medical Image Digitizer, Models CDCR 5020S, UCCR7001 and TCCR 7001

- Pathway: 510(k) (Traditional)
- Applicant: Cr Tech, Ltd.
- Decided: Sep 21, 2005 after 107 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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
The CDCR5020s,UCCR7001 and TCCR7001 are intended to be used in radiological practices as laser digitizers for phosphor storage plate. The images are sent for processing to a PC. 1. Model CDCR 5020s This device is used on cassette based x-ray systems using the standard Buckey exist on every system. After exposing the cassette which includes the phosphor plate, the plate is digitized and the digital image is transferred to the PC for processing 2. Models UCCR 7001, TCCR 7001 With these two devices the organ or object for x-ray exposure are positioned in the front of the device (near the phosphor plate which is positioned into the device) and after exposure the digitizing process is taking place, then the Digital image is transferred to the PC for processing. The only difference in the models are the way of use eather Vertical for Upright or horizontal under the Radiographic Table. ALL ABOVE MODELS ARE NOT TO BE USED FOR MAMMOGRAPHY

Source page: https://510kreport.com/device/K051494
Methodology: https://510kreport.com/methodology