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510(k) Data Aggregation
K Number
K152977Device Name
DG PACS
Manufacturer
Date Cleared
2016-01-25
(109 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DICOM GRID, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DG PACS software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
DG Viewer, a component of DG PACS, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Not intended for diagnostic use on mobile devices.
Device Description
DG PACS is considered a 'Continuous Use' device. This device is compliant with HIPAA/HITECH, Safe Harbor, and 21 CFR Part 11 regulations regarding patient privacy (such as restricting access to particular studies, logging access to data), data integrity, patient safety and best software development and validation practices.
DG PACS is a software application that handles and manipulates digital medical images for diagnostic, clinical, research or education purposes. The device does not contact the patient, nor does it control any life sustaining devices. A physician interprets images and information on DG PACS.
In general, a Picture Archiving and Communication System (PACS) is a medical imaging technology that provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS: this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is the Digital Imaging and Communications in Medicine (DICOM 3.x). Non-image data, such as scanned documents or dictated reports, may be incorporated using consumer industry standard formats like Portable Document Format (PDF) once encapsulated in DICOM.
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