Product Classification

• Device: camera, scintillation (gamma)
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IYX
• Premarket Review: Office of In Vitro Diagnostics and Radiological Health (OIR); Division of Radiological Health (DRH)
• Submission Type: 510(k)
• Regulation Number: 892.1100
• 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

Recognized Consensus Standards

• 12-284 NEMA NU 1-2012
  Performance Measurements of Gamma Cameras
• 12-337 NEMA NU 1-2018
  Performance Measurements of Gamma Cameras

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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