# K093480: Cuattro Unomd

- Pathway: 510(k) (Traditional)
- Applicant: Cuattro, LLC
- Decided: Mar 5, 2010 after 116 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900935 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063188: Del-Ims, Del Medical Imaging Corp. (2006) Summary page 1.

## Most influential descendants
- K161937: CuattroDR (2016), 0 descendants of its own

## Indications for use
The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.

Source page: https://510kreport.com/device/K093480
Methodology: https://510kreport.com/methodology