The following data is part of a premarket notification filed by Medicad Hectec Gmbh with the FDA for Medicad 4.0.
| Device ID | K170702 |
| 510k Number | K170702 |
| Device Name: | MediCAD 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | mediCAD Hectec Gmbh Opalstrasse 54 Altdorf, DE 84032 |
| Contact | Claas-fabian Luers |
| Correspondent | Claas-fabian Luers 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 | 2017-03-08 |
| Decision Date | 2018-09-07 |