The following data is part of a premarket notification filed by Visage Imaging Gmbh with the FDA for Visage Breast Density.
| Device ID | K201411 |
| 510k Number | K201411 |
| Device Name: | Visage Breast Density |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Visage Imaging GmbH Lepsiusstrasse 70 Berlin, DE 12163 |
| Contact | Stefan Strowich |
| Correspondent | Juliane Dinter QiP GmbH Struveweg 40 Ludwigsfelde, DE 14974 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2021-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251332930008 | K201411 | 000 |