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510(k) Data Aggregation
K Number
K214030Device Name
Universal DR 1748
Manufacturer
Date Cleared
2022-01-21
(29 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Konica Minolta Healthcare Americas, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
Device Description
Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.
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Why did this record match?
Applicant Name (Manufacturer) :
Konica Minolta Healthcare Americas, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EXA™ is a software device that receives digital images and data from various sources (i.e. CT 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 networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.
Device Description
EXA™ is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities and offer an interface that users find to be quite intuitive after some initial learning. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ PACS suite.
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