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510(k) Data Aggregation
K Number
K171068Device Name
OrthoView 7.2
Manufacturer
Date Cleared
2017-10-18
(191 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Meridian Technique Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OrthoView is indicated for use when a suitable licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. OrthoView provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.
Device Description
OrthoView 7.2 is dedicated, digital, pre-operative planning and templating software used to create detailed pre-operative plans quickly and easily from digital x-ray images. OrthoView 7.2 is software to be used for medical purposes, performing these purposes without being part of a hardware medical device. The device provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
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