K881386 is an FDA 510(k) clearance for the X-RAY GENERATING SYSTEM TF 1000. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by General Medical Merate S.P.A (Long Island City, US). The FDA issued a Cleared decision on July 8, 1988, 98 days after receiving the submission on April 1, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K881386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1988 |
| Decision Date | July 08, 1988 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IZO - Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |