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510(k) Data Aggregation
K Number
K012093Device Name
AETMED IMAGE PROCESSING SOFTWARE
Manufacturer
AETMED, S.P.A.
Date Cleared
2001-09-21
(78 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AETMED, S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
Device Description
The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.
The Version 3.0 DICOMed Family Software System consists of the following components:
- DICOMed DIG.IT image acquisition and CD recording station
- DICOMed P@CS image archiving manager
- DICOMed Review Cardio review workstation for cardiology
- DICOMed Review diagnostic review workstation for radiology
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