The following data is part of a premarket notification filed by General Equipment For Medical Imaging (oncovision- with the FDA for Sentinella 102; Sentinella 102 Horus.
| Device ID | K143156 |
| 510k Number | K143156 |
| Device Name: | Sentinella 102; Sentinella 102 Horus |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- EDUARDO PEIMO YUFERA 3 Valencia, ES 46012 |
| Contact | Jose Montes |
| Correspondent | Harry Van Vugt DEKRA CERTIFICATION B.V. MEANDER 1051 Arnhem, NL Nl-6825 Mj |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2014-11-18 |