Product Classification

• Device: camera, positron
• Regulation Description: Positron camera.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IZC
• Premarket Review: Office of Radiological Health (OHT8); Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.1110
• Device Class: 1
• 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

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