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MEVIS MEDICAL SOLUTIONS AG

Matched from indexed company URL: MeVis Medical Solutions AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106011763010601176MEVIS MEDICAL SOLUTIONS AG1N2026-01-01Caroline-Herschel-Str. 1 Bremen DE 28359

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260483290305MeVis AVM Contour - MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans. The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning procedures to target specific brain regions. The created contours are intended for further review, editing and approval by radiosurgery/-therapy planning specialists in third-party radiosurgery/-therapy treatment planning systems (not part of this submission). The semi-automatic registration is restricted to/requires: • X-ray, 2D DSA and 3D CT images of the brain • X-ray images must be acquired in both frontal and sagittal direction Intended Patient Population MeVis AVM Contour is used for patients diagnosed with Arteriovenous Malformations (AVM) requiring stereotactic radiosurgery (SRS). These patients are adults, 18 years and older. Intended User Profile The intended users are qualified medical professionals, working in the field of neurosurgery or radiotherapy planning (Neurosurgeons and Radiation Oncologists).1-866-533-5277support@mevis.de
04260483290312MammoScape - MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.1-866-533-5277support@mevis.de

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2083631528487755K260576MeVis AVM ContourLLZ2026-06-30
2083631470297889K232045MeVis Liver SuiteJAK2023-10-27
2083631972856245K201501VeolityOEB2021-02-23
2083631718971046K113701VISIA NEUROLLZ2012-02-16
2083631179133304K113337VISIA DYNAMIC REVIEWLNH2011-12-30
2083631436673732K043617IMAGECHECKER CT CAD SOFTWARE SYSTEMOEB2007-12-21
2083631753703850K041380IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOROEB2004-06-08
2083631427641132K040028CA-1500LLZ2004-01-22
2083631428081286K023003IMAGECHECKER-CT WORKSTATIONLLZ2002-11-20
2083631427368582

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42026-06-30
OEB32021-02-23
JAK12023-10-27
LNH12011-12-30

PMN#

GUDID#