# K210919: AcuityDRe

- Pathway: 510(k) (Traditional)
- Applicant: Radmedix, LLC
- Decided: Apr 30, 2021 after 32 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 13 generations back to K896095 (1990). 25 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201058: Accuvue+, Radmedix, LLC (2020) Summary page 4.

## Most influential descendants
- K214030: Universal DR 1748 (2022), 1 descendant of its own
- K252996: Universal 1417PI (2026), 0 descendants of its own
- K231709: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 (2023), 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/K210919
Methodology: https://510kreport.com/methodology