The following data is part of a premarket notification filed by General Equipment For Medical Imaging S.a with the FDA for Sentinella 102.
| Device ID | K110601 |
| 510k Number | K110601 |
| Device Name: | SENTINELLA 102 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A CAMINO DE VERA S/N EDIFICIO 9B Valencia, ES 46022 |
| Contact | Severine Moine |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-03-18 |