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510(k) Data Aggregation
K Number
K012327Device Name
CSIST DICOM GATEWAY/IMAGE MANAGER
Manufacturer
Date Cleared
2001-12-20
(150 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CSIST
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Device Description
CSIST DICOM Gateway and Image Manager™ consists of three modules: A DICOM Gateway, Image Manager Server, and Image Manager Client.
- The DICOM Gateway captures (2D) images from a non-DICOM imaging modality, generates a DICOM medical image, and stores it in the CSIST Image Manager Server.
- The CSIST Image Manager Server accepts DICOM medical images (2D and 3D) from different acquisition modalities, stores these in the Image Archive and then transfers the generated images to the requested Image Manager Client.
- The Image Manager Server also has a "Performed Procedure Step Manager", which can issue a message to department system scheduler/order filler and the Image Manager Server, when the acquisition modality informs the Performed Procedure Step Manager that a specific procedure step has been started or completed.
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