# K101036: Shimadzu Collimator R-20J

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Aug 26, 2010 after 134 days
- Product code: IZX (Collimator, Manual, 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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 28, 2011 · Class II · Z-0261-2013: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m)

## 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/K101036
Methodology: https://510kreport.com/methodology