# K101039: Shimadzu Collimator R-300

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Sep 20, 2010 after 159 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
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. The FDA summary names no predicate by number.

## Indications for use
This device is intended to be used in radiology. This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area. This device is for diagnostic use. This device is operated and used by Physicians and X-Ray technologist. The object of this device is total patient populations.

Source page: https://510kreport.com/device/K101039
Methodology: https://510kreport.com/methodology