# K161937: CuattroDR

- Pathway: 510(k) (Traditional)
- Applicant: Cuattro, LLC
- Decided: Oct 6, 2016 after 84 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150725: Visaris Avanse, Visaris D.O.O. Belgrade (2015) Summary page 4.
- K093480: Cuattro Unomd, Cuattro, LLC (2010) Summary page 5.

## Recalls of this device
- Oct 15, 2019 · Class II · Z-1934-2020: There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.

## Indications for use
The CuattroDR, 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/K161937
Methodology: https://510kreport.com/methodology