The following data is part of a premarket notification filed by Barco Nv with the FDA for Barco Medical Display Conformity And Consistency Software.
Device ID | K982690 |
510k Number | K982690 |
Device Name: | BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV 3407 BAY AVE. Chico, CA 95973 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV 3407 BAY AVE. Chico, CA 95973 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-03 |
Decision Date | 1998-10-06 |
Summary: | summary |