# K193360: Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

- Pathway: 510(k) (Traditional)
- Applicant: Radmedix, LLC
- Decided: Jan 2, 2020 after 29 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: 11 generations back to K801623 (1980). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160620: Visaris Vision® (Vision C, Vision U. Vision V, Vision X), Visaris D.O.O. Belgrade (2016) Summary page 4.

## Most influential descendants
- K231995: AcuityUDR (2023), 0 descendants of its own

## Indications for use
The purpose of Acuity 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/K193360
Methodology: https://510kreport.com/methodology