# K131777: Hyper Source-Unit Rotating Gamma System

- Pathway: 510(k) (Traditional)
- Applicant: Hyper Technology, Inc.
- Decided: Feb 28, 2014 after 256 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: 4 generations back to K924849 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102533: Rotating Gamma System Infini (Infini), Masep Medical Science & Tech.Development (Shenzhen (2011) Summary page 2.

## Indications for use
The Hyper Source-unit Rotating Gamma System (SGS-I+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.

Source page: https://510kreport.com/device/K131777
Methodology: https://510kreport.com/methodology