The following data is part of a premarket notification filed by Nec Display Solutions Ltd. with the FDA for Diagnostic Imaging Color Lcd Monitor.
| Device ID | K161057 |
| 510k Number | K161057 |
| Device Name: | Diagnostic Imaging Color LCD Monitor |
| Classification | Display, Diagnostic Radiology |
| Applicant | NEC DISPLAY SOLUTIONS LTD. 4-28, MITA 1-CHOME, MINATO-KU Tokyo, JP |
| Contact | Satoru Kotani |
| Correspondent | David Cheng TOP VICTORY ELECTRONICS (TAIWAN) CO., LTD. 10F, NO. 230, LIANCHENG RD. ZHONGHE DIST. New Taipei City, TW 23559 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2016-05-13 |
| Summary: | summary |