Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device x-ray, computed tomography, cone-beam
Regulation Description Computed tomography x-ray system.
Definition Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Physical State X-ray machine not intended for quantitative imaging.
Technical Method Uses x-ray scanning to produce cone-beam computed tomographic images.
Target Area Whole body except dental structures.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeSFV
Premarket Review Office of Radiological Health (OHT8)
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-