The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 21.3 Inch (54 Cm) Color Digital Mammography Lcd Monitor Ccl550i2(cl21550).
| Device ID | K151007 |
| 510k Number | K151007 |
| Device Name: | 21.3 Inch (54 Cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) |
| Classification | Display, Diagnostic Radiology |
| Applicant | JVC KENWOOD CORPORATION 3-12, MORIYA-CHO, KANAGAWA-KU Yokohama-shi, JP 221-0022 |
| Contact | Tsukasa Tashiro |
| Correspondent | Tsukasa Tashiro JVC KENWOOD CORPORATION 3-12, MORIYA-CHO, KANAGAWA-KU Yokohama-shi, JP 221-0022 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-05-08 |
| Summary: | summary |