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510(k) Data Aggregation
K Number
K153026Device Name
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement
Manufacturer
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
Date Cleared
2016-05-25
(222 days)
Product Code
IYE, LNH
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
Device Description
The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch.
The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge.
The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform.
The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.
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