# K983917: Theratron Elite

- Pathway: 510(k) (Special)
- Applicant: Theratronics, Inc.
- Decided: Dec 4, 1998 after 30 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894165 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964606: Theratron 780E, Theratronics, Inc. (1997) Summary page 1.
- K964607: Theraton 1000E, Theratronics, Inc. (1997) Summary page 1.

## Most influential descendants
- K053485: Theratron Equinox, Models 80 CM and 100 CM (2006), 0 descendants of its own

## Recalls of this device
- Jul 8, 2004 · Not classified · Z-1183-06: 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.
- Jul 8, 2004 · Not classified · Z-1184-06: 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.

## Indications for use
The device is intended to be used in: Delivering the intended dose of radiation at a specified position; Delivering the radiation in accordance with the selected relationship of the radiation to the patient (fixed or moving beam therapy, beam modifying device, etc); Delivering the radiation without causing unnecessary risk to the patient, the operator, other persons or the immediate environment.

Source page: https://510kreport.com/device/K983917
Methodology: https://510kreport.com/methodology