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510(k) Data Aggregation
K Number
K063327Device Name
ORTHOVIEW
Manufacturer
MERDIAN TECHNIQUE, LTD.
Date Cleared
2006-11-22
(19 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MERDIAN TECHNIQUE, 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 and fixation devices, for the purposes of choosing the nature and characteristics of the prosthetic/fixation device to be used when planning a potential surgical procedure. In addition, Trauma and Osteotomy modules and Trauma Templates are provided to extend the range of functionality available to the healthcare professional.
Device Description
Orthoview™ is intended to provide the following for the Operator (a suitably qualified and trained healthcare professional):
- To be downloaded from the Internet and to be unlocked using a Meridian . Technique Ltd provided key.
- . Grant access rights only to authorized users (via PC password system).
- . Receive X-Ray images in a digital format from third party X-Ray machines/ X-Ray digitisers or PACS systems.
- Process such images securely with respect to patient confidentiality, patient . identification and image integrity.
- . Allow the image to be retrieved for processing as follows:
- Scaling of the image. o
- Selection of appropriate prosthetic and fixing device manufacturer and ୍ size range templates.
- O Overlaying the template on the image and permitting selection of appropriate size of prosthetic/fixing.
- o Provide additional functionality in the form of Trauma and Osteotomy modules
- Print and archive appropriate reports. ୍
- Receive and store templates for prostheses and fixations supplied by ் Meridian Technique Ltd for particular manufacturer's range of products.
- o Provide traceability of operator, date and decisions made.
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