Search Results
Found 1 results
510(k) Data Aggregation
K Number
K102533Device Name
ROTATING GAMMA SYSTEM INFINI (INFINI)
Date Cleared
2011-03-22
(200 days)
Product Code
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
**MASEP MEDICAL SCIENCE **& TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rotating Gamma System Infini™ (Infini™) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
Device Description
The Rotating Gamma System Infini™ is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures. The system is composed of four parts:
- 60Co Radiation sources
- Main unit (including mechanical system and electric system)
- Stereotactic system
- Treatment planning system
Ask a Question
Ask a specific question about this device
Page 1 of 1