# K083029: Model R605DASM Automatic X-Ray Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Ralco S.R.L.
- Decided: Dec 5, 2008 after 56 days
- Product code: IZW (Collimator, Automatic, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- 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 K990423 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072780: Model R302DACS/a Automatic X-Ray Collimator, Ralco S.R.L. (2007) Summary page 1.
- K050092: R605 Facs Collimeter, Omega Medical Imaging, Inc. (2005) Summary page 1.

## Indications for use
Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Source page: https://510kreport.com/device/K083029
Methodology: https://510kreport.com/methodology