Product Classification

• Device: interventional fluoroscopic x-ray system
• Regulation Description: Image-intensified fluoroscopic x-ray system.
• Definition: Interventional fluoroscopy
• Physical State: Fluoroscopic X-Ray system
• Technical Method: Fluoroscopy
• Target Area: Human body
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: OWB
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.1650
• 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
• 12-290 IEC 61910-1 Edition 1.0 2014-09
  Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
• 12-329 IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
• 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
• 12-351 IEC 60601-2-43 Edition 3.0 2022-12
  Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
• 12-364 IEC 61223-3-8 Edition 1.0 2024-03
  Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc