Product Classification

• Device: unit, x-ray, intraoral
• Regulation Description: Intraoral source x-ray system.
• Regulation Medical Specialty: Dental
• Review Panel: Radiology
• Product Code: EAP
• Submission Type: 510(k)
• Regulation Number: 872.1810
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.