K944149 is an FDA 510(k) clearance for the MICRO X-80 HF. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on September 16, 1994, 22 days after receiving the submission on August 25, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K944149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1994 |
| Decision Date | September 16, 1994 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZO — Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |