# K970647: Our Rotating Gamma System

- Pathway: 510(k) (Traditional)
- Applicant: Our Scientific Intl., Inc.
- Decided: May 20, 1997 after 89 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Leksell Gamma Unit Model 23004, Type B: named in the summary without a submission number

## Most influential descendants
- K190844: Akesis Galaxy (2019), 3 descendants of its own
- K200050: Akesis Galaxy RTx (2020), 2 descendants of its own
- K060314: Rotating Gamma System.  Gamma Art-6000 (2006), 2 descendants of its own
- K172706: GammaPod - Model A (2017), 1 descendant of its own
- K203250: TaiChiC (2021), 0 descendants of its own

## Indications for use
The OUR Rotatifig” Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.

Source page: https://510kreport.com/device/K970647
Methodology: https://510kreport.com/methodology