K954666 is an FDA 510(k) clearance for the MPH50, MPH65, AND MPH80. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on November 24, 1995, 45 days after receiving the submission on October 10, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K954666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1995 |
| Decision Date | November 24, 1995 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZO - Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |