# K062788: Collimator, Model M-38

- Pathway: 510(k) (Traditional)
- Applicant: Umi International
- Decided: Dec 28, 2006 after 101 days
- Product code: KPW (Device, Beam Limiting, X-Ray, Diagnostic)
- 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray tube of the x-ray system.

Source page: https://510kreport.com/device/K062788
Methodology: https://510kreport.com/methodology