The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 21.3 Inch (54 Cm) Inch Monochrome Digital Mammography Lcd Monitor Ms35i2 (ml21035).
| Device ID | K133686 |
| 510k Number | K133686 |
| Device Name: | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) |
| Classification | System, Image Processing, Radiological |
| Applicant | JVC KENWOOD CORPORATION 3-12, MORIYACHO, KANAGAWA-KU Yokohama-shi, Kanagawa, JP 221-0022 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro JVC KENWOOD CORPORATION 3-12, MORIYACHO, KANAGAWA-KU Yokohama-shi, Kanagawa, JP 221-0022 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-02 |
| Decision Date | 2014-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00805736053661 | K133686 | 000 |
| 04996005103036 | K133686 | 000 |
| 04996005103029 | K133686 | 000 |
| 04996005103012 | K133686 | 000 |
| 00046838076534 | K133686 | 000 |
| 00046838076527 | K133686 | 000 |
| 00046838076510 | K133686 | 000 |