# K150191: GammaBeam 500

- Pathway: 510(k) (Traditional)
- Applicant: Best Theratronics Limited
- Decided: Apr 17, 2015 after 79 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863180 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863180: Theratron-Phoenix, Aecl Medical (1986) Summary page 4.

## 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/K150191
Methodology: https://510kreport.com/methodology