Product Classification

• Device: x-ray, tomography, computed, dental
• 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 Code: OAS
• Premarket Review: Office of In Vitro Diagnostics and Radiological Health (OIR); Division of Radiological Health (DRH)
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 12-302 IEC 60601-2-44 Edition 3.2: 2016
  Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography

Third Party Review

Not Third Party Eligible