(48 days)
The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.
The proposed device is a mobile x-ray system, it uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging. This system consists of a mobile base unit, combined X-ray tube assembly, collimator, frame, X-ray flat panel detector, and image processing system.
This device is a Diagnostic X-ray System, which is a hardware device. The provided text indicates that no clinical study was included in this submission. Therefore, there is no acceptance criteria or study data for device performance as requested for AI/software devices.
However, the submission does mention various performance data related to the hardware itself, which are not based on clinical efficacy or diagnostic accuracy. These include:
- Electrical safety and electromagnetic compatibility (EMC): The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009, IEC 62471 standard for safety, and IEC 60601-1-2: 2014 standard for EMC. Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017.
- Software Verification and Validation: The Embedded software and the workstation software were considered a "Moderate" level of concern and were verified and validated according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." They comply with FDA recognized standard IEC 62304.
- Cybersecurity: Documentation was provided according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- DICOM: DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016).
- Usability Testing: Usability validation was performed and complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.
- Risk Management: Activities were performed and documented according to FDA recognized standard ISO 14971 Second edition 2007-03-01.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation for the x-ray flat panel detector.
Since this is a hardware device clearance, and not an AI/software as a medical device (SaMD) or an AI-powered diagnostic device, the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or provided in this 510(k) summary.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.