# K060314: Rotating Gamma System.  Gamma Art-6000

- Pathway: 510(k) (Special)
- Applicant: American Radiosurgery, Inc.
- Decided: Apr 6, 2006 after 57 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 K970647 (1997). 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)
- K970647: Our Rotating Gamma System, Our Scientific Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K172706: GammaPod - Model A (2017), 1 descendant of its own
- K180571: GammaPod (2018), 0 descendants of its own

## Indications for use
The Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.

Source page: https://510kreport.com/device/K060314
Methodology: https://510kreport.com/methodology