K951883 is an FDA 510(k) clearance for the PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on May 24, 1995, 51 days after receiving the submission on April 3, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K951883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | May 24, 1995 |
| Days to Decision | 51 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 |