K944816 is an FDA 510(k) clearance for the SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096). This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on February 8, 1995, 132 days after receiving the submission on September 29, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K944816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1994 |
| Decision Date | February 08, 1995 |
| Days to Decision | 132 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 |