K040125 is an FDA 510(k) clearance for the SENOGRAPHIC STEREO. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Ge Medical Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on April 19, 2004, 90 days after receiving the submission on January 20, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K040125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | April 19, 2004 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZH - System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |