(206 days)
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.
Not Found
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.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.