# K863180: Theratron-Phoenix

- Pathway: 510(k) (Traditional)
- Applicant: Aecl Medical
- Decided: Oct 27, 1986 after 70 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K150191: GammaBeam 500 (2015), 0 descendants of its own
- K142219: GammaBeam 100 (2014), 0 descendants of its own

## Recalls of this device
- Jul 8, 2004 · Not classified · Z-1182-06: The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

Source page: https://510kreport.com/device/K863180
Methodology: https://510kreport.com/methodology