# K191451: CMDR 2CW (Multiple models)

- Pathway: 510(k) (Special)
- Applicant: Minxray, Inc.
- Decided: Jul 3, 2019 after 33 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: 10 generations back to K896095 (1990). 22 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171353: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris, Minxray, Inc. (2017) Summary page 4.

## Most influential descendants
- K200726: AcuityPDR (2020), 9 descendants of its own
- K201058: Accuvue+ (2020), 4 descendants of its own
- K210919: AcuityDRe (2021), 3 descendants of its own
- K202353: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (2020), 2 descendants of its own
- K214030: Universal DR 1748 (2022), 1 descendant of its own

## Indications for use
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.

Source page: https://510kreport.com/device/K191451
Methodology: https://510kreport.com/methodology