Product Classification

• Device: camera, multi format, radiological
• Regulation Description: Medical image hardcopy device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LMC
• Submission Type: Enforcement Discretion
• Regulation Number: 892.2040
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Documents

• Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
• Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions  

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.