# K042840: Shimadzu Collimator R-20J

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Dec 3, 2004 after 50 days
- Product code: IZX (Collimator, Manual, 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
Longest line of descent: 1 generation back to K031771 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031771: Shimadzu Collimator R-30H, Shimadzu Corp. (2003) Summary page 3.

## Indications for use
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 intended to be used in the radiology. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.

Source page: https://510kreport.com/device/K042840
Methodology: https://510kreport.com/methodology