Product Classification

• Device: analyzer, medical image
• Regulation Description: Medical image analyzer.
• Definition: For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: MYN
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.2070
• 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 Standard

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

Guidance Document

• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible