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510(k) Data Aggregation
K Number
K073176Device Name
KANTERON DICOM STATION (KDS), MODEL 3.0
Manufacturer
Date Cleared
2008-03-19
(127 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MONICA VEYTIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Kanteron DICOM Station (KDS) is a software device intended for viewing of images acquired from computer tomography (CT), magnetic resonance (MR), computed radiography (CR), digital radiography (DR), ultrasound (US), and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.
Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images must only be viewed with a monitor approved by the FDA for viewing mammographic images.
It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
The KDS is not intended for use as a preoperative surgical planning system and must not be used for this purpose.
Device Description
The KDS provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. Kanteron DICOM Station (KDS) runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images. Language files are separate from image software, allowing software to be provided in various languages.
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