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510(k) Data Aggregation
K Number
K982535Device Name
INSIGHT DIAGNOSTIC IMAGING WORKSTATION
Manufacturer
NEO IMAGERY TECHNOLOGIES, INC.
Date Cleared
1998-12-21
(154 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEO IMAGERY TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user or supplied by NIT. The NIT InSight™ software receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
Device Description
The InSight™ Diagnostic Imaging Workstation receives image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft Windows NT™ operating system makes the InSight™ Diagnostic Imaging Workstation easy to use and capable of being integrated with your other computer needs.
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K Number
K965179Device Name
INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
Manufacturer
NEO IMAGERY TECHNOLOGIES, INC.
Date Cleared
1997-07-03
(191 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEO IMAGERY TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InSight™ Diagnostic Imaging Workstation must be used by or on the order of a physician. The system receives digital information from scanning devices and manipulates image data for the purpose of image characterization, enhancement, communication, archiving, and real-time 3D visualization. The system is designed as an aide to trained medical practitioners in the diagnostic process. Only qualified personnel should service system hardware and software.
Device Description
The InSight™ Diagnostic Imaging Workstation provides real-time 3-D visualization, communication, archiving, characterization, and image enhancement with digital information received from medical scanning devices. System utilizes IBM compatible PC with Intel "X"86 family microprocessors and Microsoft Windows NT™ operating system for ease of maintenance and cost.
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