# K053029: NDR+/Diva-D

- Pathway: 510(k) (Abbreviated)
- Applicant: Nical Spa
- Decided: Jan 6, 2006 after 71 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: 2 generations back to K911454 (1991). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012490: Orion Digital Imaging System, Infimed, Inc. (2002) Summary page 1.

## Most influential descendants
- K080859: DRF 4343 (2008), 2 descendants of its own
- K103038: Duet DRF (2011), 1 descendant of its own
- K202235: ArtPIX DRF (2020), 0 descendants of its own

## Indications for use
The indication for use of the NDR+/DIVA-D is: DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION

Source page: https://510kreport.com/device/K053029
Methodology: https://510kreport.com/methodology