# K083640: Digital X-Ray Imaging System, Model: CXD-DR80D

- Pathway: 510(k) (Traditional)
- Applicant: Choong Wae Medical Corp.
- Decided: Jun 29, 2009 after 202 days
- Product code: KPR (System, X-Ray, Stationary)
- 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 K862120 (1986). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001) Summary page 1.
- K080064: Flaatz 750, Drtech Corp. (2008) Summary page 1.

## Most influential descendants
- K102327: Clearvision DR 7000F (2012), 0 descendants of its own
- K101779: Clearvision DR 2000 Digital Radiography X-Ray System (2011), 0 descendants of its own

## Indications for use
The CXD-DR80D Digital X-ray Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. The CXD-DR80D Digital X-ray Imaging System utilizes the FLAATZ 750 Detector, manufactured by DRTECH Co. (K080064)

Source page: https://510kreport.com/device/K083640
Methodology: https://510kreport.com/methodology