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The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are intended for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

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The provided text is a 510(k) Premarket Notification from the FDA, specifically for the "PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System".

This document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) document is a regulatory approval letter based on establishing substantial equivalence to a predicate device. It confirms that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent for the stated indications for use.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Name: PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System
• Regulation Number & Name: 21 CFR 892.1650, Image-intensified fluoroscopic x-ray system
• Regulatory Class: II
• Product Code: OWB and JAA
• Indications for Use: The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional, and angiography procedures/applications.
• Substantial Equivalence: A declaration that the device is substantially equivalent to legally marketed predicate devices.

To answer your detailed request about acceptance criteria and study data, clinical trial reports or performance testing documentation would be required, which are not part of this 510(k) FDA letter.

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