Product Classification

• Device: display, diagnostic radiology
• Regulation Description: Medical image management and processing system.
• Definition: The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
• Physical State: Hardware and embedded software
• Technical Method: Hardware and embedded sofware for displaying radiological images.
• Target Area: Whole body
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: PGY
• Premarket Review: Office of Radiological Health (OHT8); Division of Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.2050
• 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

• 12-344 IEC 62563-2 Edition 1.0 2021-11
  Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc