The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Biopsee, Mobile Us.
| Device ID | K170841 |
| 510k Number | K170841 |
| Device Name: | BiopSee, Mobile US |
| Classification | System, Image Processing, Radiological |
| Applicant | MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
| Contact | Johannes Messow |
| Correspondent | Johannes Messow MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-21 |
| Decision Date | 2017-07-26 |
| Summary: | summary |