K021945 is an FDA 510(k) clearance for the PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE). This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Planmed OY (Roselle, US). The FDA issued a Cleared decision on February 21, 2003, 253 days after receiving the submission on June 13, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K021945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2002 |
| Decision Date | February 21, 2003 |
| Days to Decision | 253 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 |