# K090578: Shimadzu Collimator R-30H

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Nov 6, 2009 after 248 days
- Product code: IZW (Collimator, Automatic, 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
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.

## Recalls of this device
- Oct 28, 2011 · Class II · Z-0260-2013: 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
The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

Source page: https://510kreport.com/device/K090578
Methodology: https://510kreport.com/methodology