# K874687: Colli-Matetm Model NO. B800

- Pathway: 510(k) (Traditional)
- Applicant: Summit Industries, Inc.
- Decided: Dec 30, 1987 after 47 days
- Product code: IZX (Collimator, Manual, Radiographic)
- Device class: 2
- Regulation: 21 CFR 892.1610
- Recalls of this device: 3 (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
- Aug 10, 2007 · Not classified · Z-1217-2007: The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
- Aug 10, 2007 · Not classified · Z-1218-2007: The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
- Aug 10, 2007 · Not classified · Z-1216-2007: The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

Source page: https://510kreport.com/device/K874687
Methodology: https://510kreport.com/methodology
