# K242948: Adora DRFi (04550010)

- Pathway: 510(k) (Traditional)
- Applicant: Nrt X-Ray A/S
- Decided: Dec 23, 2024 after 89 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152928: Multitom Rax, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Indications for use
The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows the acquisition of a wide range of X-ray examinations. It is intended for use in generating diagnostic radiographic and radioscopic images of human anatomy. The Adora DRFi X-ray system is intended for use by trained and qualified personnel at the entire body of both adult and pediatric patients, and exposures may be acquired with the patient in supine, standing or sitting positions as well as with the patient in e.g., a wheelchair or on a stretcher. Radiographic procedures can take place with the detector in free position as well as fixed in the docking station; whereas radioscopic procedures may only take place when the detector is fixed in the docking station. The Adora DRFi is not for mammography examinations.

Source page: https://510kreport.com/device/K242948
Methodology: https://510kreport.com/methodology