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510(k) Data Aggregation
K Number
K162285Device Name
EBM iDO Viewer 1.2.1
Manufacturer
Date Cleared
2017-01-27
(165 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EBM Technologies Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EBM iDO Viewer 1.2.1 software is intended to display images from CT. MR . CR. US. XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.
Device Description
EBM iDO Viewer 1.2.1 is a software device that can be installed on Apple iPad Pro Through wireless network, user can login, query and display the images which are stored in heir existing EBM PACS server. The device can be installed in iOS 5.0 or later version platform such as iPad, but can't be installed in platforms other than iOS 5.0 or later version . It will be almost the same image quality of CT, MR , US, XA and SC as displayed on iPad Pro when it is used for diagnosis purpose. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro.
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K Number
K142514Device Name
UniWeb 8.0
Manufacturer
Date Cleared
2014-12-18
(101 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EBM Technologies Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted 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™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
Device Description
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted 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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