(144 days)
The KrystalRAD (ATAL8) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The KrystalRAD (ATAL8) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRAD (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station.
The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network.
Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
The provided text describes the KrystalRAD (ATAL8) System, a flat-panel digital X-ray detector, and its 510(k) submission (K102285) for market clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the DRTech FLAATZ 750 (K080064). The acceptance criteria and supporting study are primarily focused on this comparison and general safety/effectiveness rather than a detailed clinical performance study with specific acceptance criteria for a diagnostic task.
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 here are implicitly or explicitly based on comparing the KrystalRAD (ATAL8) System's technical specifications and performance metrics directly against its predicate device, the DRTech FLAATZ 750 (K080064). The goal is to demonstrate "substantial equivalence," meaning that the new device is as safe and effective as the legally marketed predicate.
| Metric / Characteristic | Acceptance Criteria (from predicate K080064) | Reported Device Performance (KrystalRAD (ATAL8) System) |
|---|---|---|
| Indication for Use | General radiographic images of human anatomy; replaces film/screen in general diagnostic procedures (excluding fluoroscopic, angiographic, mammographic) | Same as predicate. |
| User Interface | Software Driven Touch Panel LCD + remote control unit + remote console | Same as predicate. |
| Software | ECOM OmniVue | OmniVision |
| Panel Shape | Square | Square Panel |
| Detector Size | 42.9 x 42.9 cm | 43 x 43 cm |
| Dimensions (W x L x H) | 482 x 482 x 35 mm | 500 x 500 x 40 mm |
| Pixel Pitch | 168 µm | 143 µm |
| Image Size | 3072 x 3072 pixels | 3072 x 3072 pixels |
| Selenium Thickness | 500 µm | no selenium |
| Weight (Detector) | 6.2 kg | 12.7 kg |
| Materials | Amorphous Selenium (a-Se) Detector | Amorphous Silicon (a-Si) |
| DQE | 48.5% @ 0.5 lp/mm | 68% @ 0.5 lp/mm |
| MTF | 78% @ 3.5 lp/mm | 52.5% @ 3.5 lp/mm |
| Resolution | 3.6 lp/mm | 3.5 lp/mm |
| Ghosting |
§ 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.