# K083645: Radstar Family, Models: Radstar 4343 & Variations

- Pathway: 510(k) (Traditional)
- Applicant: 5 Star Medical, Inc.
- Decided: Feb 24, 2009 after 77 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: 5 generations back to K803130 (1981). 22 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081648: Digital Radiography Cxdi-60G, Canon, Inc. (2008) Summary page 1.
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K131211: Dicompacs DX-R with Flat Panel (2013), 3 descendants of its own
- K141440: Dicompacs DX-R with Flat Panel (2014), 2 descendants of its own
- K142718: Radlink GPS (2014), 1 descendant of its own
- K101435: Imix Panorad and Somarad (2010), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Source page: https://510kreport.com/device/K083645
Methodology: https://510kreport.com/methodology