Product Classification

• Device: digital breast tomosynthesis
• Definition: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
• Physical State: Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.
• Technical Method: Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ¿slices¿ through the breast.
• Target Area: Breast
• Review Panel: Radiology
• Product Code: OTE
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: PMA
• Device Class: 3
• 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

• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
• 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

Third Party Review

Not Third Party Eligible