K160933 is an FDA 510(k) clearance for the Discovery NM 750b Bopsy. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on November 18, 2016, 228 days after receiving the submission on April 4, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K160933 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2016 |
| Decision Date | November 18, 2016 |
| Days to Decision | 228 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 |