Product Classification

• Device: system, tomography, computed, emission
• Regulation Description: Emission computed tomography system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KPS
• Submission Type: 510(k)
• Regulation Number: 892.1200
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final

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.