The following data is part of a premarket notification filed by Hectec Gmbh with the FDA for Medicad Classic.
| Device ID | K140434 |
| 510k Number | K140434 |
| Device Name: | MEDICAD CLASSIC |
| Classification | System, Image Processing, Radiological |
| Applicant | HECTEC GMBH OTTOSTR. 16 Landshut, Bavaria, DE 84030 |
| Contact | Thomas Wengenmayer |
| Correspondent | Thomas Wengenmayer HECTEC GMBH OTTOSTR. 16 Landshut, Bavaria, DE 84030 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-20 |
| Decision Date | 2014-06-05 |
| Summary: | summary |