Product Classification

• Device: full field digital,system,x-ray,mammographic
• Regulation Description: Full-field digital mammography system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: MUE
• Submission Type: 510(k)
• Regulation Number: 892.1715
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• NEMA XR 22-2006 "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
• NEMA XR 23-2006 "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
• IEC 62220-1-2 Edition 1.0 (2007-06) Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
• IEC 61223-3-2 (2007) Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment

Guidance Document

• Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System  

Third Party Review

Not Third Party Eligible