The following data is part of a premarket notification filed by Medicad Hectec Gmbh with the FDA for Medicad Web.
Device ID | K183412 |
510k Number | K183412 |
Device Name: | MediCAD Web |
Classification | System, Image Processing, Radiological |
Applicant | mediCAD Hectec GmbH Opalstrasse 54 Altdorf, DE 84032 |
Contact | Claas-fabian Lueers |
Correspondent | Claas-fabian Lueers mediCAD Hectec GmbH Opalstrasse 54 Altdorf, DE 84032 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-10 |
Decision Date | 2019-10-31 |