# K052938: CR-PRO

- Pathway: 510(k) (Traditional)
- Applicant: Eradlink, Inc.
- Decided: Nov 17, 2005 after 28 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
Longest line of descent: 4 generations back to K952914 (1995). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003256: PCCR Digital Imaging Device, Orex Computed Radiography, Ltd. (2000) Summary page 1.
- K020243: Laserpro 16, Eradlink, Inc. (2002) Summary page 3.

## Most influential descendants
- K142718: Radlink GPS (2014), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel PentiumN 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites. This device is not to be used for primary imaging diagnosis in mammography.

Source page: https://510kreport.com/device/K052938
Methodology: https://510kreport.com/methodology