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510(k) Data Aggregation
K Number
K073124Device Name
COLLIMARE COLLIMATOR FAMILY
Manufacturer
COLLIMARE, LLC
Date Cleared
2007-11-16
(10 days)
Product Code
IZW
Regulation Number
892.1610Why did this record match?
Applicant Name (Manufacturer) :
COLLIMARE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
Device Description
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.
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