K092471 is an FDA 510(k) clearance for the MODEL SENTINELLA 102. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by General Equipment For Medical Imaging, S.A. (Valencia, ES). The FDA issued a Cleared decision on October 2, 2009, 52 days after receiving the submission on August 11, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K092471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2009 |
| Decision Date | October 02, 2009 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYX - Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |