Data / Medical devices / Germany / Visage Imaging GmbH
Visage Imaging GmbH: FDA-registered device maker in Berlin, Germany, 3 510(k) clearances
Visage Imaging GmbH is registered with the FDA (registration 9616251) in Berlin, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616251
- FEI number
- 3003772586
- Address
- Lepsiusstrasse 70, Berlin, Germany, 12163
- Owner or operator
- Visage Imaging GmbH (9040273)
- Roles
- Manufacturer
- First device listed
- June 12, 2014
- Registered through
- 2026
- Brand names listed
- Visage 7, Visage 7 Enterprise, Visage 7 Enterprise Imaging Platform, Visage Breast Density, Visage Ease Pro, Visage PACS/CS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2021 | K201411 | Visage Breast Density | QIH | Substantially Equivalent | Visage Imaging GmbH | accessdata.fda.gov |
| April 28, 2015 | K142196 | Visage Ease Pro | LLZ | Substantially Equivalent | Visage Imaging GmbH | accessdata.fda.gov |
| December 12, 2008 | K082269 | VISAGE PACS, VERSION 6.0/CS 3.1 | LLZ | Substantially Equivalent | Visage Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated January 29, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.