K910967 is an FDA 510(k) clearance for the NEUROCAM. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 3, 1991, 119 days after receiving the submission on March 6, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K910967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1991 |
| Decision Date | July 03, 1991 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IYX - Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |