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510(k) Data Aggregation
K Number
K043483Device Name
RADIN, MODEL V 3.0
Manufacturer
SOHARD AG
Date Cleared
2005-01-28
(42 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SOHARD AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RADIN can be used whenever digital images and associated data acquired or generated by different third party modalities have to be accepted, displayed, transmitted, stored, distributed, processed and archived in order to be available for professional health care personnel. RADIN is not intended to assist the healthcare personnel in diagnosis. RADIN can be used together with appropriate and proper installed computer platforms according to the recommendations made in the labeling.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users are trained healthcare professionals including but not limited to physicians, licenced practitioners, nurses.
Device Description
RADIN 3.0 is a system to distribute medical images and reports within and outside of health care environments. It is available as a stand-alone software package. RADIN consists of the following set of software modules: RADIN.online, RADIN.web, RADIN.archive. RADIN offers three types of clients: RADIN.Classic Client, RADIN.Expert Client, RADIN.Expert dual monitor Client. RADIN requires standard PC-Hardware.
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