# K061873: VERT-X

- Pathway: 510(k) (Traditional)
- Applicant: Direx Systems Corp.
- Decided: Aug 18, 2006 after 46 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to P840008 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053640: Integra, Direx Systems Corp. (2006) Summary page 1.

## Indications for use
Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

Source page: https://510kreport.com/device/K061873
Methodology: https://510kreport.com/methodology