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The BIOK 7600 is intended for use by a qualified doctor or technologist on both and pediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK7600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.

The BIOK7600 is not intended for mammography.

The BIOK7600 sensor is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600.

The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600, through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight:

Automatically optimizes the image quality
Permanently stores the image to its database
Displays the image to the user
Allows the user to perform image manipulations and to add annotations
Allows the user store and transfer the images in DICOM format.

The provided text describes a 510(k) premarket notification for the BIOK7600 Flat Panel Detector, asserting its substantial equivalence to predicate devices. However, it does not contain a detailed study with specific acceptance criteria, reported performance values, or methodological details like sample size, expert qualifications, or ground truth establishment that would allow for a comprehensive answer to your request.

The document states:

• "Clinical considerations concurrence study: A set of test images have been submitted along with the equivalent images from the predicate device."
• "The BIOK7600 produces images of similar quality and characteristics that are equivalent to those of the predicate device, as demonstrated in the clinical considerations - concurrence study provided in this submission."

This indicates that a comparison study was performed, but the specifics of how "similar quality and characteristics" were determined, what the acceptance criteria were, and the results are not explicitly detailed in the provided text.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the study methodology (sample size, expert details, adjudication, MRI-MC, standalone performance, ground truth type, or training set specifics) based solely on the given input.

To answer your request, the actual "clinical considerations concurrence study" document would be needed.

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