The following data is part of a premarket notification filed by Barco Nv Display Systems with the FDA for Medis 55mp1h Single-head Medical Diagnostic Display System.
| Device ID | K001752 |
| 510k Number | K001752 |
| Device Name: | MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV DISPLAY SYSTEMS 8524 VILA LA JOLLA DR. SUITE 161 La Jolla, CA 92037 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson BARCO NV DISPLAY SYSTEMS 8524 VILA LA JOLLA DR. SUITE 161 La Jolla, CA 92037 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2000-07-19 |