K934373 is an FDA 510(k) clearance for the MOBILE SOPHIE MODIFICATION. 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 April 7, 1994, 211 days after receiving the submission on September 8, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K934373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1993 |
| Decision Date | April 07, 1994 |
| Days to Decision | 211 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 |