K973400 is an FDA 510(k) clearance for the MAMMOTEST ADAPTER DRIVER. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on November 10, 1997, 62 days after receiving the submission on September 9, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K973400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1997 |
| Decision Date | November 10, 1997 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |