K133686 is an FDA 510(k) clearance for the 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Jvckenwood Corporation (Yokohama-Shi, Kanagawa, JP). The FDA issued a Cleared decision on January 6, 2014, 35 days after receiving the submission on December 2, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K133686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2013 |
| Decision Date | January 06, 2014 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |