(109 days)
Scannerside Dose check is intended for providing Computed Tomographic (CT) Dose Check feature to CT X-ray systems. The Scannerside Dose Check is specifically indicated for providing the Computed Tomography Dose Check feature with notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose is above a predefined threshold. This device is intended for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
Not Found
This document is an FDA 510(k) clearance letter for a device called "ScannerSide DoseCheck." It doesn't contain information about the device's technical specifications, acceptance criteria, or the study conducted to prove it meets those criteria. The letter primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe acceptance criteria, nor does it detail a study proving device performance against such criteria. It's a regulatory clearance, not a technical performance report.
To answer your request, I would need a document from Right Dose Inc. (the manufacturer) that details their V&V (Verification and Validation) study for the ScannerSide DoseCheck device, including the testing methodology, acceptance criteria, and study results.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.