Unit, X-ray, Intraoral

Device Code: 5255

Product Code(s): EAP

Device Classification Information

• Device Type ID: 5255
• Device Name: Unit, X-ray, Intraoral
• Regulation Description: Intraoral Source X-ray System.
• Regulation Medical Specialty: Dental
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 872.1810 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EAP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-221 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
• 12-310 IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION
  Medical Electrical Equipment - Part 2-63: Particular Requirements For The Basic Safety And Essential Performance Of Dental Extra-oral X-ray Equipment

Total Product Life Cycle

• Device Type ID: 5255
• Device: Unit, X-ray, Intraoral
• Product Code: EAP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Intraoral Source X-ray System.
• CFR Regulation Number: 872.1810 [🔎]

TPLC Last Update: 2019-04-02 21:03:08