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510(k) Data Aggregation
K Number
K081076Device Name
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
Manufacturer
VELOCITY MEDICAL SOLUTIONS, LLC
Date Cleared
2008-06-20
(65 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VELOCITY MEDICAL SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.
Device Description
Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. Version 2.0 of the product contains the additional features of: Automated deformable registration. Anatomical atlas based segmentation tools. Operating systems compatibility with MicroSoft Windows XP Home and Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard). VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
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K Number
K070248Device Name
VELOCITYAIS
Manufacturer
VELOCITY MEDICAL SOLUTIONS, LLC
Date Cleared
2007-03-01
(35 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VELOCITY MEDICAL SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VelocityAIS is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS is not intended for mammography diagnosis.
Device Description
VelocityAIS is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. VelocityAIS is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
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