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U.S. Department of Health and Human Services

Product Classification

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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 CodeQHY
Premarket Review Office of Radiological Health (OHT8)
Division of 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible