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510(k) Data Aggregation
K Number
K122174Device Name
PEDIATRIC POSITIONER PAD SET
Manufacturer
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
Date Cleared
2012-11-16
(116 days)
Product Code
KXH
Regulation Number
892.1830Why did this record match?
Product Code :
KXH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.
Device Description
The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.
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