Product Classification

• Device: camera, scintillation (gamma)
• Regulation Description: Scintillation (gamma) camera.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IYX
• Submission Type: 510(k)
• Regulation Number: 892.1100
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• NEMA NU 1-2007 Performance Measurements of Gamma Cameras

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.