The following data is part of a premarket notification filed by Masep Medical Science & Tech.development (shenzhen with the FDA for Rotating Gamma System Infini (infini).
| Device ID | K102533 |
| 510k Number | K102533 |
| Device Name: | ROTATING GAMMA SYSTEM INFINI (INFINI) |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN 55 NORTHREN BLVD SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN 55 NORTHREN BLVD SUITE 200 Great Neck, NY 11021 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2011-03-22 |
| Summary: | summary |