# K951372: Philips Gallileo Automatic Collimator (or Beam Limiting Device)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: May 4, 1995 after 38 days
- Product code: IZW (Collimator, Automatic, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 7, 2008 · Not classified · Z-1886-2008: The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.

Source page: https://510kreport.com/device/K951372
Methodology: https://510kreport.com/methodology