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510(k) Data Aggregation
K Number
K071166Device Name
UNIWEB, VERSION 5.0
Manufacturer
Date Cleared
2007-07-23
(88 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats.
UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities.
UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting.
UniWeb™ will be utilized only on FDA approved monitors used for mammography.
Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians.
This product will only use lossless compression or no compression when displaying mammography images.
For image diagnosis, this device can only be used by trained professionals.
Device Description
UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
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K Number
K062743Device Name
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
Manufacturer
Date Cleared
2006-10-31
(47 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K023394Device Name
UNISIGHT SYSTEM WITH UNIGATE
Manufacturer
Date Cleared
2003-01-07
(90 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UniSight™ system with UniGate™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
Device Description
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