# K082627: Minxray, Model CMDR-1S and CMDR-1S-Mil

- Pathway: 510(k) (Traditional)
- Applicant: Minxray, Inc.
- Decided: Nov 7, 2008 after 59 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K981556 (1998). 7 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042361: Digital Portable X-Ray Units, Model SP-HF-4.0 D, Sedecal USA, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K171353: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (2017), 12 descendants of its own
- K191451: CMDR 2CW (Multiple models) (2019), 11 descendants of its own
- K200726: AcuityPDR (2020), 9 descendants of its own

## Indications for use
This digital radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays..

Source page: https://510kreport.com/device/K082627
Methodology: https://510kreport.com/methodology
