(170 days)
The FLAATZ 760 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
The FLAATZ 760 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The FLAATZ 760 system includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.
The provided text describes the 510(k) submission for the FLAATZ 760, a radiographic image acquisition device. The study presented is a non-clinical and clinical comparison to a predicate device, FLAATZ 750, to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FLAATZ 760 are primarily based on demonstrating substantial equivalence to the predicate device, FLAATZ 750, across various performance metrics. The reported device performance is directly compared to the predicate.
| Metric (Acceptance Criteria relative to FLAATZ 750) | FLAATZ 760 Reported Performance | FLAATZ 750 (Predicate) Performance |
|---|---|---|
| DQE @ 0.5lp/mm | 45.1% | 40% |
| MTF @ 3lp/mm | 78% | 77.7% |
| Resolution | 3.0 lp/mm | 3.0 lp/mm |
| Ghosting @ RQA5 Condition |
§ 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.