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510(k) Data Aggregation
K Number
K011827Device Name
ORTELIUS 800
Manufacturer
ORTHOSCAN LTD.
Date Cleared
2001-08-28
(77 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Applicant Name (Manufacturer) :
ORTHOSCAN LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.
The Ortelius 800 may be used in medical clinics/institutes.
Device Description
The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.
The Ortelius 800 enables the following features:
- · Spine curve reconstruction based on the points sampled by the Sensor.
- · Automatically calculated spine deformity angles of the primary curve.
- · Indication of the extreme vertebra from which the spine deformity angle was calculated.
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