# K131211: Dicompacs DX-R with Flat Panel

- Pathway: 510(k) (Traditional)
- Applicant: Oehm Und Rehbein GmbH
- Decided: Nov 5, 2013 after 190 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: 6 generations back to K803130 (1981). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083645: Radstar Family, Models: Radstar 4343 & Variations, 5 Star Medical, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K100234: HM-Lamp II, Hillusa, Inc. (2010). Our reading of the summary gave K100234, FDA’s number for HM-Lamp II (Hillusa, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “AeroDR System”. Kept off the family tree.

## Most influential descendants
- K141440: Dicompacs DX-R with Flat Panel (2014), 2 descendants of its own
- K142718: Radlink GPS (2014), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
The dicomPACS®1 DX-R with fiat panel 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 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/K131211
Methodology: https://510kreport.com/methodology