# K941363: Phantom

- Pathway: 510(k) (Traditional)
- Applicant: Dynarad Corp.
- Decided: Jul 20, 1994 after 121 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 3, 2006 · Not classified · Z-0049-2007: The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.

Source page: https://510kreport.com/device/K941363
Methodology: https://510kreport.com/methodology