Product Classification

• Device: system, image management, ophthalmic
• Regulation Description: Medical image management and processing system.
• Regulation Medical Specialty: Radiology
• Review Panel: Ophthalmic
• Product Code: NFJ
• Premarket Review: Ophthalmic Devices (DHT1A); Ophthalmic Devices (DHT1A)
• 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 Standards

• 12-349 NEMA PS 3.1 - 3.20 2022d
  Digital Imaging and Communications in Medicine (DICOM) Set
• 12-352 NEMA PS 3.1 - 3.20 2023e
  Digital Imaging and Communications in Medicine (DICOM) Set

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