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U.S. Department of Health and Human Services

Product Classification

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Device x-ray, tomography, computed, dental
Regulation Description Computed tomography x-ray system.
Definition Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Physical State X-ray machine
Technical Method Uses x-ray scanning to produce computed tomographic images
Target Area Mouth and associated stuctures
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOAS
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1750
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible