The following data is part of a premarket notification filed by Barco Nv with the FDA for Coronis 3mp Medicl Flat Panel Display System.
Device ID | K013922 |
510k Number | K013922 |
Device Name: | CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV P.O. BOX 12038 La Jolla, CA 92039 -2038 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV P.O. BOX 12038 La Jolla, CA 92039 -2038 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-27 |
Decision Date | 2002-01-28 |
Summary: | summary |