Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K201411 |
Device Name |
Visage Breast Density |
Applicant |
Visage Imaging GmbH |
Lepsiusstrasse 70 |
Berlin,
DE
12163
|
|
Applicant Contact |
Stefan Strowich |
Correspondent |
QiP GmbH |
Struveweg 40 |
Ludwigsfelde,
DE
14974
|
|
Correspondent Contact |
Juliane Dinter |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/28/2020 |
Decision Date | 01/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|