# K093572: R650 Qdasm Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: Feb 3, 2010 after 77 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: 3 generations back to K990423 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K050092: R605 Facs Collimeter, Omega Medical Imaging, Inc. (2005) Summary page 1.

## Indications for use
The Omega R650 ODASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.

Source page: https://510kreport.com/device/K093572
Methodology: https://510kreport.com/methodology