# K091364: Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4

- Pathway: 510(k) (Traditional)
- Applicant: Oehm Und Rehbein GmbH
- Decided: Dec 11, 2009 after 217 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K896095 (1990). 8 ancestors in all.
58 later devices descend from it; 5 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070618: Dicompacs, Model 5, Oehm Und Rehbein GmbH (2007) Summary page 1.

## Most influential descendants
- K110033: Feel-DRCS (2011), 16 descendants of its own
- K101517: Sedecal Mobile Digital Diagnostic X-Ray (2011), 16 descendants of its own
- K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (2016), 14 descendants of its own
- K100449: Minxray Model CMDR-2S (2010), 14 descendants of its own
- K141885: CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray (2014), 13 descendants of its own

## Indications for use
dicomPACS and dicomPACS DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS and dicomPACS DX-R also provides services for administering the data. dicomPACS DX-R can control X-ray generators. dicomPACS DX-R is not approved for the acquisition of mammographic image data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MR resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using dicomPACS and dicomPACS DX-R are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. dicomPACS and dicomPACS DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

Source page: https://510kreport.com/device/K091364
Methodology: https://510kreport.com/methodology