The following data is part of a premarket notification filed by Nec Display Solutions Ltd. with the FDA for Md322c8 31.5 Diagnostic Imaging Lcd Monitor.
| Device ID | K150145 |
| 510k Number | K150145 |
| Device Name: | MD322C8 31.5 Diagnostic Imaging LCD Monitor |
| Classification | Display, Diagnostic Radiology |
| Applicant | NEC DISPLAY SOLUTIONS LTD. 4-28 MITA 1-CHOME, MINATO-KU,TOKYO, 108-0023 Tokyo, JP 108-0023 |
| Contact | Satoru Kotani |
| Correspondent | Tony Hsu PRODIGY TECHNOLOGY CONSULTANT CO., LTD. 1F, NO. 181, SEC 2, WUNHUA 1ST RD. LINKOU New Taipei City, TW |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-02-06 |
| Summary: | summary |