Product Classification

• Device: cone, radiographic
• Regulation Description: Diagnostic x-ray beam-limiting device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IZT
• Submission Type: Enforcement Discretion
• Regulation Number: 892.1610
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

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.