Product Classification

• Device: digitizer, image, radiological
• Regulation Description: Medical image digitizer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LMA
• Submission Type: Enforcement Discretion
• Regulation Number: 892.2030
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

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.