Product Classification

• Device: system, x-ray, fluoroscopic, non-image-intensified
• Regulation Description: Non-image-intensified fluoroscopic x-ray system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: JAB
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.1660
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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