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510(k) Data Aggregation
K Number
K093444Device Name
EXAPACS
Manufacturer
Date Cleared
2010-02-04
(91 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDINCOM TECHNOLOGY CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.
ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Device Description
ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.
ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.
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