# K954129: Spectradigital Series V250DSP

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: Dec 22, 1995 after 112 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K991129: Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal (TI) Crystal (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K954129
Methodology: https://510kreport.com/methodology