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510(k) Data Aggregation
K Number
K052341Device Name
AJEX 9015/135H PORTABLE X-RAY
Manufacturer
Date Cleared
2005-10-07
(42 days)
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
JPI AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on Tactographic incored. applications, and ing diagnostic radiographic exposures of body parts.
-The AJEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures.
-The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that are not mobile .
Device Description
The AJEX 9015H and AJEX 135H are portable x-ray units which operate at 110V 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
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