# K964583: XRT-7.0

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jan 17, 1997 after 63 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K945512 (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)
- K945512: HRSW Option for CT Twin Flash, Elscint, Inc. (1995) Summary page 1.

Source page: https://510kreport.com/device/K964583
Methodology: https://510kreport.com/methodology