(90 days)
This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
The provided text is a 510(k) premarket notification approval letter for the "Model PKP-06000 CCD Camera." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and contact information for further inquiries.
Therefore, I cannot provide a response to your request based on the given input text. The information required (acceptance criteria, study details, human-in-the-loop performance, etc.) is typically found in the 510(k) summary or detailed device description, which is not present here.
§ 892.1620 Cine or spot fluorographic x-ray camera.
(a)
Identification. A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.(b)
Classification. Class II.