# K964607: Theraton 1000E

- Pathway: 510(k) (Traditional)
- Applicant: Theratronics, Inc.
- Decided: May 28, 1997 after 191 days
- Product code: IWD (Device, Beam Limiting, Teletherapy, 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
Longest line of descent: 1 generation back to K894165 (1990). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894165: Theratron 1000, Theratronics, Inc. (1990) Summary page 1.

## Most influential descendants
- K983917: Theratron Elite (1998), 1 descendant of its own
- 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-1181-06: 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
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

Source page: https://510kreport.com/device/K964607
Methodology: https://510kreport.com/methodology