The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 21.3 Inch Monochrome Digital Mammography Lcd Monitor Ms55i2 (ml21055, Md211g5).
| Device ID | K131137 |
| 510k Number | K131137 |
| Device Name: | 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) |
| Classification | System, Image Processing, Radiological |
| Applicant | JVC KENWOOD CORPORATION 300-OYA UEDA-SHI Nagano-ken, JP 386-0192 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro JVC KENWOOD CORPORATION 300-OYA UEDA-SHI Nagano-ken, JP 386-0192 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-07-18 |
| Summary: | summary |