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510(k) Data Aggregation
K Number
K111776Device Name
DELTAVIEW MODEL 2.1
Manufacturer
RIVERAIN MEDICAL GROUP,LLC
Date Cleared
2011-12-28
(188 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RIVERAIN MEDICAL GROUP,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.
Device Description
DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.
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K Number
K092363Device Name
SOFTVIEW, MODEL 2.01
Manufacturer
RIVERAIN MEDICAL GROUP
Date Cleared
2010-03-18
(225 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RIVERAIN MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SoftView is intended to generate an enhanced, secondary digital radiographic image of the chest. The enhanced AP or PA image of the chest provides improved visibility of the lung parenchyma through bone suppression and tissue equalization, and may facilitate discerning the presence or absence of nodules. The SoftView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians on patients with risk of having lung nodules and is not intended to be used on pediatric patients.
Device Description
SoftView is a dedicated post-processing application which suppresses bone structures from digital radiographic image of the chest.
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K Number
K071492Device Name
FIRSTVIEW
Manufacturer
RIVERAIN MEDICAL GROUP,LLC
Date Cleared
2007-08-28
(90 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RIVERAIN MEDICAL GROUP,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FirstView™ is intended to display and manipulate x-ray images.
The FirstView™ is indicated for displaying and manipulating chest x-ray images. It acts as an interface with the CAD component, if installed or available at the clinical site, and provides display of information contained within the DICOM header of the images. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians.
Device Description
The FirstView™ consists of a dedicated server that has been programmed with a database and server software, as well as client software that is loaded onto an existing workstation. New images, which may be a chest x-ray or CAD result, are sent to the FirstView™ server from a Digital or from the PACS network, prompting FirstView to query the PACS for additional images related to that study. The FirstView™ server manages the images within its Riverain proprietary database.
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