# K031771: Shimadzu Collimator R-30H

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Aug 21, 2003 after 73 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K090578: Shimadzu Collimator R-30H (2009), 0 descendants of its own
- K042840: Shimadzu Collimator R-20J (2004), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K031771
Methodology: https://510kreport.com/methodology