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510(k) Data Aggregation
K Number
K241223Device Name
eRAD PACS
Manufacturer
Date Cleared
2024-10-31
(183 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
eRAD, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces.
eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.
eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.
The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light systems.
Lossy compressed images and digitized film images must not be used for primary diagnosis of mammography studies. When displaying mammography images for clinical interpretation, only monitors having regulatory clearance for mammography interpretation should be used.
Device Description
eRAD PACS is a software-only medical image management and processing system, comprised of a central systems manager component, diagnostic viewing components, and an archiving component.
The system is used for patients who undergo an imaging procedure deemed necessary by the patient's physician.
The data flow is as follows:
- Patient and procedure information is optionally acquired by the central system manager to prepare for the acquisition of image objects.
- -Image objects are acquired from the image sources, such as imaging modalities, PACS, data archives, and other devices.
- After receiving the procedure information or the image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving component.
- When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information from a workstation by selecting the item from the operator's worklist.
- The image data is transmitted to and rendered on the user's workstation using the diagnostic viewing components.
- -After reviewing the images in the diagnostic viewer, the user optionally creates a clinical report using a text editor or a commercially available speech recognition solution.
- -Once the central system manager registers a report, the report is available for access by the referring physician, or it can be exported into a third-party information system.
- At some configured point in time, the image data and the report information are delivered to the archiving component for backup and long-term storage.
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K Number
K120995Device Name
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
Manufacturer
Date Cleared
2012-12-03
(245 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ERAD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
eRAD PACS/ eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.
The eRAD PACS/ eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS/ eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.
The eRAD PACS/ eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities.
Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
eRAD PACS/ eRAD RIS/PACS Software Product is a PACS system, comprised of acquisition components, a central systems manager component, diagnostic viewing components, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archiving a component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is transmitted to and rendered on the user's workstation using the diagnostic viewing components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the diction and transcribe it to text. Once eRAD PACS's central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
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K Number
K061421Device Name
ERAD PACS
Manufacturer
Date Cleared
2006-07-25
(64 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ERAD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Device Description
eRAD PACS is a PACS system, comprised of acquisition components (GatewayServer and SendServer), a central system manager component (SmartServer), a diagnostic workstation component (Workstation and Viewer), (and an archiving component (ArchiveServer). The data flow is such that patient and on and is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager information of and retrieves relevant procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is transmitted to by oreading and the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once eRAD PACS's central system manager registers a and the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in internal format, and to make that information available across a network via web and customized user interfaces.
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