# K972365: Compact or Comp-X

- Pathway: 510(k) (Traditional)
- Applicant: Eurotec, S.R.L.
- Decided: Dec 12, 1997 after 170 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K955036 (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)
- K955036: Mobile X-Ray System, Shimadzu Corp. (1995) Summary page 1.

## Indications for use
THE UNIT IS INTENDED FOR USE ON GENERAL RADIOGRAPHIC PROCEDURES.

Source page: https://510kreport.com/device/K972365
Methodology: https://510kreport.com/methodology