52 results
·
70ms
·
Sources: EU EUDAMED, US FDA
TeraRecon Cardiac.Chambers.MR (1.0.0)
FDA 510(k)
FDA Class 2
·Radiology
IIVS INTEGRATED IMAGE VIEWING STATION
FDA 510(k)
FDA Class 1
·Radiology
AQUARIUS WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
INTUITION
FDA 510(k)
FDA Class 2
·Radiology
Neuro.Al Algorithm
FDA 510(k)
FDA Class 2
·Radiology
INTUITION - TDA, TVA, PARAMETRIC MAPPING
FDA 510(k)
FDA Class 2
·Radiology
AQUARIUSAPS SERVER
FDA 510(k)
FDA Class 2
·Radiology
TeraRecon Neuro
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·TeraRecon, Inc.·1 device
Intuition
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·TeraRecon, Inc.·1 device
HD 60146453 0001
Certificate
MDD Annex II (excluding section 4)·TeraRecon, Inc.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
Terarecon GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices