Product Classification

• Device: image-intensified fluoroscopic x-ray system, mobile
• Regulation Description: Image-intensified fluoroscopic x-ray system.
• Definition: Fluoroscopy of the human body.
• Physical State: Hardware
• Technical Method: X-ray transmission through human body
• Target Area: Human Body
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: OXO
• Submission Type: 510(k)
• Regulation Number: 892.1650
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

Not Third Party Eligible