# K050092: R605 Facs Collimeter

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: Jan 31, 2005 after 17 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: 2 generations back to K990423 (1999). 2 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K031597: Dunlee Format Collimator Family, Philips Medical Systems North America Co. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K040182: Advantech Model R600/800 series collimators. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K072780: Model R302DACS/a Automatic X-Ray Collimator (2007), 2 descendants of its own
- K093572: R650 Qdasm Collimator (2010), 0 descendants of its own
- K091517: Ralco, Model R225 Acs (2009), 0 descendants of its own
- K083029: Model R605DASM Automatic X-Ray Collimator (2008), 0 descendants of its own

## Indications for use
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Source page: https://510kreport.com/device/K050092
Methodology: https://510kreport.com/methodology