Product Classification

• 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 Code: OAS
• 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: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 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
• 12-345 IEC 61223-3-7 Edition 1.0 2021-12
  Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography

Guidance Document

• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible