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510(k) Data Aggregation
K Number
K994054Device Name
ISSA PHAROS
Manufacturer
Date Cleared
2000-02-14
(76 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VAMS TEC, D.O.O.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
Device Description
The ISSA™ Imaging and PHAROS Communication Products is a lightly integrated package of software elements designed to provide:
- DICOM compliant telemedicine viewer interface
- 2D viewer of all stored medical images .
- . Telemedicine communication system
In general terms, Issa PHAROS contains two software applications, Issa and Pharos. Both belong to the group of software produsts for medical image management and manipulations are designed to fit equaly to small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments. Image management and manipulation here means acquisition, archival, processing and transmission or distribution.
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