(45 days)
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans.
Fluoro Scan Option is an almost "real time" reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.
The ProSpeed Family of Systems are x-ray computed tomography scanners based on the ProSpeed Plus platform consisting of a gantry, patient table, console, computer and associated accessories.
Materials: Materials and construction are equivalent to the CT ProSpeed Plus and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.
Design: The design is essentially the same as the CT ProSpeed with Hillight detector (K944013) the difference being that the Fluoro Scan option includes an in-room monitor and a control pedestal. The control pedestal allows for gantry tilt and table positioning as well as initiation and termination of scanning.
Energy Source and Exposure Levels: The energy source and exposure levels are the same as those previously submitted for ProSpeed with HiLight Detector.
Principals of Operation: The same as ProSpeed with HiLight Detector.
This document is a 510(k) summary for a medical device called the "CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options." The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, the document focuses on regulatory submission and does NOT contain information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, or details of a study proving device performance against specific criteria.
The document primarily describes:
- Product Identification: Name, manufacturer, distributor.
- Marketed Devices: States that it's comparable and substantially equivalent to existing CT systems.
- Device Description: Discusses the components (gantry, patient table, console, computer, accessories), materials (equivalent to CT ProSpeed Plus, compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J), design (similar to CT ProSpeed with Hilight detector, with added Fluoro Scan option features), energy source and exposure levels (same as ProSpeed with HiLight Detector), and principles of operation (same as ProSpeed with HiLight Detector).
- Indications for Use: Head and whole body x-ray computed tomography applications. It also details the specific options:
- Warp Scan Option: 0.8 second 360-degree helical or axial scans.
- Fluoro Scan Option: "Real time" reconstruction (Smart Recon) with 0.8 to 1.6 seconds display latency, in-room monitor with 3 or 6 frame/sec display.
- SmartPrep Option: Aids in triggering scans after contrast injection, displays images with regions of interest, graphs CT numbers.
- Comparison with Predicate: States the device is substantially equivalent to currently marketed head and whole body x-ray CT systems in design, material, energy source, and radiation characteristics.
- Adverse Effects on Health: Identifies potential hazards and controls (Fault Tree Analysis, system evaluation, adherence to standards).
- Conclusions: Claims no new safety risks and performs as well as or better than market devices.
Therefore, it is impossible to complete the requested table and answer the study-related questions based on this document. The text focuses on establishing substantial equivalence for regulatory purposes, not on presenting performance metrics against defined acceptance criteria from a specific study.
§ 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.