# K103038: Duet DRF

- Pathway: 510(k) (Abbreviated)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Mar 29, 2011 after 166 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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: 9 generations back to K801623 (1980). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080859: DRF 4343, Villa Sistemi Medicali S.P.A. (2008) Summary page 1.

## Most influential descendants
- K202235: ArtPIX DRF (2020), 0 descendants of its own

## Indications for use
The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use

Source page: https://510kreport.com/device/K103038
Methodology: https://510kreport.com/methodology
