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510(k) Data Aggregation
K Number
K961753Device Name
SHARED VISION(PART NUMBER SV 0015)
Manufacturer
Date Cleared
1996-07-25
(80 days)
Product Code
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
IMAGELABS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks.
Device Description
Shared Vision is a computerized, enhanced electronic Image Display Software System designed for clinical applications to allow physicians or other health care providers to remotely view and analyze patient Image Display data. This system is suited for various computer networks. Both devices use a computer program to display a pre-digitized patient image file. Both devices nun under a computer operating system. Both devices use the computer operating system to access the displayed image. Both devices output a display image that resembles a conventional image. Both devices retain an electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a computer operating system.
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