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
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.1715
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-165 NEMA XR 22-2006 (R2020)
  "Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
• 12-166 NEMA XR 23-2006 (R2020)
  "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
• 12-176 IEC 61223-3-2 Second eidtion 2007-07
  Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
• 12-213 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
• 12-365 IEC 60627 Edition 3.0 2013-07
  Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
• 12-366 IEC 61223-3-6 Edition 1.0 2020-02
  Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

Guidance Documents

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

• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc