K062393 is an FDA 510(k) clearance for the GE VANTAGE PET NEURO SOFTWARE. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on September 1, 2006, 16 days after receiving the submission on August 16, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K062393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2006 |
| Decision Date | September 01, 2006 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |