K931049 is an FDA 510(k) clearance for the ADVANTX SYSTEM. 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 May 19, 1993, 79 days after receiving the submission on March 1, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K931049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1993 |
| Decision Date | May 19, 1993 |
| Days to Decision | 79 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 |