The following data is part of a premarket notification filed by Barcoview, Medical Imaging Systems with the FDA for Nio 5mp, Model Mdng-5121.
| Device ID | K073205 |
| 510k Number | K073205 |
| Device Name: | NIO 5MP, MODEL MDNG-5121 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCOVIEW, MEDICAL IMAGING SYSTEMS 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Contact | Neil Phillips |
| Correspondent | Neil Phillips BARCOVIEW, MEDICAL IMAGING SYSTEMS 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001466 | K073205 | 000 |