(40 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
This device in an x-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm , that is equipped with an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.
The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. INFX-8000C w/Spot Fluoro Option. This document describes a modification to an existing device, an interventional X-ray system, to improve workflow and reduce radiation exposure via auto-collimation.
However, the 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of MRMC or standalone studies, or ground truth information based solely on the provided text.
The document primarily focuses on establishing substantial equivalence to a predicate device (INFX-8000C K081621) due to a modification for workflow improvement and radiation dose reduction, rather than presenting a performance study with detailed acceptance criteria. The modification is specifically noted as: "The modification allows for the auto-collimation to a smaller field of few that the operator sets on the last image displays (LIH)."
The safety section mentions compliance with regulations like Quality System Regulations, ISO 13485, IEC60601-1 standards, and 21 CFR §1020, but these are general regulatory compliances, not specific performance acceptance criteria for a new feature validated by a study.
§ 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.