Product Classification

• Device: system, x-ray, fluoroscopic, image-intensified
• Regulation Description: Image-intensified fluoroscopic x-ray system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: JAA
• Submission Type: 510(k)
• Regulation Number: 892.1650
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-43 - Ed. 2.0 2010-03 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
• IEC 60601-2-43 - Ed. 1.0 Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
• IEC PAS 61910-1 First Edition 2007-07 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
• NEMA XR 24-2008 Primary user controls for interventional angiography x-ray equipment
• NEMA XR7-1995 (R2000) High-Voltage X-Ray Cable Assemblies and Receptacles

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.