# K214012: Straight Arm DDR

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Healthcare Americas, Inc.
- Decided: Jan 12, 2022 after 21 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: 7 generations back to K981556 (1998). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193225: KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography, Konica Minolta Healthcare Americas, Inc. (2020) Summary page 4.

## Most influential descendants
- K221853: Otc DDR (2022), 0 descendants of its own

## Indications for use
The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).

Source page: https://510kreport.com/device/K214012
Methodology: https://510kreport.com/methodology