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510(k) Data Aggregation
K Number
K060566Device Name
MINXRAY, MODELS HFP24 AND HFP40
Manufacturer
Date Cleared
2006-04-05
(33 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
MIKASA X-RAY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MinXray HFP24 and HFP40 is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. These units are specifically designed for podiatric and extremity applications.
Device Description
MinXray HFP24 and HFP40 are x-ray units which operate from 120 V 50-60~ AC. They utilize a newly designed high frequency inverter designed to be mounted on a stand. The usual safety precautions regarding the use of x-rays must be observed by the operator.
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