The following data is part of a premarket notification filed by General Equipment For Medical Imaging (oncovision- with the FDA for Mammi.
| Device ID | K140996 |
| 510k Number | K140996 |
| Device Name: | MAMMI |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- EDUARDO PEIMO YUFERA 3 Valencia, ES 46012 |
| Contact | Jose Montes |
| Correspondent | J.a. Van Vugt DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-04-17 |
| Decision Date | 2014-06-11 |