# K955395: DAR-2400-15B/30B

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Dec 11, 1995 after 17 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071717: GE Oec Altitude (2007), 0 descendants of its own
- K052039: GE Oec Altitude (2005), 0 descendants of its own
- K032443: Digital Angiography System Digitex Safire (2004), 0 descendants of its own
- K973342: DAR-3000B (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K955395
Methodology: https://510kreport.com/methodology