Visage Imaging GmbH

FDA Device Registration & Listing · Berlin, DE · Registration 9616251

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616251
FEI Number
3003772586
Entity Name
Visage Imaging GmbH
City/State/Country
Berlin, DE
Establishment Address
Lepsiusstrasse 70, Berlin 12163, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Visage Imaging GmbH (Owner Number: 9040273)
Owner / Operator Contact Address
Lepsiusstrasse 70, --, Berlin, DE-BE 12163, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142196
PMA Number
N/A

All Registered Proprietary Names

Visage Breast Density Visage Ease Pro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2021-04-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-05-08

Official Correspondent

No official correspondent registered.

US Agent Details

Brad Levin Business: General Manager, North America Email: blevin@visageimaging.com Phone: (404) 4549670

Related Public Records

Same Entity

Visage Imaging GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3042852277 REMEDY LOGIC New York, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616251. Last updated year: 2026. Please use registration number 9616251 when referencing this establishment in official correspondence.
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