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510(k) Data Aggregation
K Number
K100094Device Name
CARESTREAM IMAGE SUITE
Manufacturer
CARESTREAM HEATLH, INC.
Date Cleared
2010-03-11
(57 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CARESTREAM HEATLH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States.
Device Description
CARESTREAM Image Suite is a stand-alone, self-contained radiographic imaging system designed to provide a low-cost platform to manage medical images, reports, patient/exam information and workflow in small clinics. The system performs capture, processing, review, archiving, and printing of radiographic images as well as report writing and printing and is designed to run on a PC workstation. The CARESTREAM Image Suite is designed to be simple and intuitive to both use and service.
CARESTREAM Image Suite is designed as a hardware-independent system and may be interfaced with verified and validated image acquisition devices from both Carestream Health and 3rd party vendors, Carestream Health PACS system, and other 3rd party PACS systems. The system will acquire an image from either a DirectView Classic CR or a Point-of-Care 140/145 or 360 CR and be PC and monitor independent.
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