K914267 is an FDA 510(k) clearance for the GE 4096 PLUS & GE 2048. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 16, 1992, 297 days after receiving the submission on September 23, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K914267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1991 |
| Decision Date | July 16, 1992 |
| Days to Decision | 297 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 |