# K102533: Rotating Gamma System Infini (Infini)

- Pathway: 510(k) (Traditional)
- Applicant: Masep Medical Science & Tech.Development (Shenzhen
- Decided: Mar 22, 2011 after 200 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: 3 generations back to K924849 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041125: Masep SRRS Gamma Rays Stereotactic Radiation Therapy System for Heads (Masep Gamma Therapy System), Masep Med Science & Tech. Development (Shenzhen) C (2004) Summary page 2.
- K061941: Leksell Gamma Knife Perfexion, Model 715000, Elekta Instrument AB (2006) Summary page 1.

## Most influential descendants
- K131777: Hyper Source-Unit Rotating Gamma System (2014), 0 descendants of its own

## Indications for use
The Rotating Gamma System InfiniTM (InfiniTM) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.

Source page: https://510kreport.com/device/K102533
Methodology: https://510kreport.com/methodology