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The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Fusion Flat Panel." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

Therefore, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document states:

• Device Name: Fusion Flat Panel
• Indications For Use: The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
• Regulation Number: 21 CFR 892.1650
• Regulation Name: Image-intensified fluoroscopic x-ray system (though the indications for use explicitly exclude fluoroscopy, this is likely a broader regulatory classification that applies)
• Product Code: MOB

To answer your request, you would need a different document, such as a summary of safety and effectiveness, a clinical study report, or internal validation data for the device.

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