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 | K162052 |
| 510k Number | K162052 |
| Device Name: | Sentinella 102, Sentinella 102 Horus |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- EDUARDO PRIMO YUFERA, N 3 Valencia, ES 46012 |
| Contact | Jose Montes |
| Correspondent | Jose Montes GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- EDUARDO PRIMO YUFERA, N 3 Valencia, ES 46012 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437018413027 | K162052 | 000 |
| 08437018413010 | K162052 | 000 |