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510(k) Data Aggregation
K Number
K964229Device Name
REGULUS NAVIGATOR
Manufacturer
COMPASS INTL., INC.
Date Cleared
1997-08-19
(300 days)
Product Code
HAW, 84H
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
COMPASS INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intraoperative Guidance Device to Localize a Surgical Field for Intra/Extracranial Usage
Device Description
The Regulus Navigator (RN) incorporates preoperative CT and MRI images into a surgical computer system. A minimum of three points (reference markers or anatomical points) are selected with the RN on the patient in the operating room (OR space) and the corresponding locations on the images (image space) are determined and selected by the surgeon. These corresponding points in the OR space and the image space are utilized to calculate a "transformation matrix" which is used to transform the location of the RN instrument into the image space. The location of the RN instrument is interactively displayed as a cursor on the diagnostic images and then used as a tool to guide the surgeon during the intra/extracranial procedure.
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