# K221853: Otc DDR

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Healthcare Americas, Inc.
- Decided: Jul 27, 2022 after 30 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: 8 generations back to K981556 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214012: Straight Arm DDR, Konica Minolta Healthcare Americas, Inc. (2022) Summary page 4.

## Indications for use
The OTC 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/K221853
Methodology: https://510kreport.com/methodology