Product Classification

• Device: solid state fluoroscopic x-ray imager
• Regulation Description: Image-intensified fluoroscopic x-ray system.
• Definition: To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.
• Physical State: Typically contained within a plastic or metal housing and typically flat and rectangular. May be connected to other components of a fluoroscopic x-ray system through wired or wireless means.
• Technical Method: Uses a indirect-conversion (x-ray scintillator based) or direct-conversion (x-ray photoconductor based) methods to convert fluoroscopic x-ray patterns into electric signals.
• Target Area: May be used to image any part of the body which is/may be in motion.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: QHY
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.1650
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible