# K072006: DAR-9400F

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Aug 31, 2007 after 39 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050925 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062360: Bransist Safire, Shimadzu Corp. (2006) Summary page 3.
- K052500: DAR-8000F, Shimadzu Medical Systems (2005) Summary page 3.

## Indications for use
This device is intended to be used in the diagnosis of circulatory vascular system. This device is operated and used by the physicians and X-ray technologist.

Source page: https://510kreport.com/device/K072006
Methodology: https://510kreport.com/methodology