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PXP-HF family of portable X-Ray systems are designed for a general radiographic application in a field or medical clinics use. There are only difference in radiation output and x-ray tube between the portable X-Ray systems.

PXP-20HF and PXP-40HF portables are used with mobile stand systems for Nursing home-care or Private home-care application. When the patients are sick at home, it is very expensive to bring the patients to a hospital by ambulance transportation service for X-ray examination. Therefore hospital sends this portable equipment to the patient's houses and take a X-ray picture on site. This portable and mobile systems has been used on a battle field because of easy mobility,

PXP-15HF portable X-ray systems has been used for Foot & Hand- care clinics or sport medicine group in sport complex or sport stadium for X-ray examination of athletics who are injured during a game.

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This document is a 510(k) clearance letter from the FDA for a portable X-ray system, the PXP-HF 15/20/40. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The letter primarily focuses on the substantial equivalence determination of the device to legally marketed predicate devices and outlines regulatory compliance requirements. It confirms that the device can be marketed based on this determination.

Therefore, I cannot provide the requested information from this document.

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