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510(k) Data Aggregation
K Number
K032401Device Name
ORTHOVIEW
Manufacturer
OMSBAR LTD
Date Cleared
2003-08-14
(10 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
OMSBAR LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthoview™ is indicated for use when a suitably licensed and qualified healthcare professional requires access to medical images with the intention of using such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Device Description
Orthoview™ is a software device that permits the orthopedic surgeon to pre-plan surgical procedures by permitting image viewing and manipulation and prosthetic template overlay within a PACS workstation or standalone environment.
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