# K231995: AcuityUDR

- Pathway: 510(k) (Abbreviated)
- Applicant: Radmedix, LLC
- Decided: Oct 25, 2023 after 112 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 12 generations back to K801623 (1980). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193360: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard, Radmedix, LLC (2020) Summary page 4.

## Indications for use
The purpose of AcuityUDR is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.

Source page: https://510kreport.com/device/K231995
Methodology: https://510kreport.com/methodology