# K200726: AcuityPDR

- Pathway: 510(k) (Traditional)
- Applicant: Radmedix, LLC
- Decided: Apr 13, 2020 after 24 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: 11 generations back to K896095 (1990). 23 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191451: CMDR 2CW (Multiple models), Minxray, Inc. (2019) Summary page 4.

## Most influential descendants
- 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
- K253058: Portable DR Imaging System (2026), 0 descendants 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/K200726
Methodology: https://510kreport.com/methodology