Product Classification

• Device: table, radiographic, tilting
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IXR
• Premarket Review: Office of Radiological Health (OHT8); Division of Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(K) Exempt
• Regulation Number: 892.1980
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 12-317 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Third Party Review

Not Third Party Eligible