# K080859: DRF 4343

- Pathway: 510(k) (Traditional)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Jun 4, 2008 after 69 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: 8 generations back to K801623 (1980). 61 ancestors in all.
2 later devices descend 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)
- K053029: NDR+/Diva-D, Nical Spa (2006) Summary page 1.
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K050925: Digital Radiography System Radspeed Safire, Shimadzu Corp. (2005) Summary page 1.

## Most influential descendants
- K103038: Duet DRF (2011), 1 descendant of its own
- K202235: ArtPIX DRF (2020), 0 descendants of its own

## Indications for use
The DRF 4343 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/K080859
Methodology: https://510kreport.com/methodology