# K032443: Digital Angiography System Digitex Safire

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Feb 20, 2004 after 196 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: 1 generation back to K955395 (1995). 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)
- K955395: DAR-2400-15B/30B, Shimadzu Medical Systems (1995) Summary page 3.

## Indications for use
This device is intended to be used in the Angiography in Hospital with the X-ray devices. 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 DAR-5000 is the same as that of predicate device DAR-2400-155B/30B (K955395). Consequently, the indications for use of the DAR-5000 are also the same as that of the DAR-2400-15B/30B (K955395), and there are no additional indications.

Source page: https://510kreport.com/device/K032443
Methodology: https://510kreport.com/methodology