Product Classification

• Device: system, x-ray, angiographic
• Regulation Description: Angiographic x-ray system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IZI
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.1600
• Device Class: 2
• 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

• 12-286 NEMA XR 27 Amendment 1-2013
  X-ray equipment for interventional procedures - User Quality Control Mode
• 12-348 IEC 60601-2-54 Edition 2.0 2022-09
  Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Guidance Document

• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible