Device, Beam Limiting, X-ray, Diagnostic

Device Code: 5372

Product Code(s): KPW

Device Classification Information

• Device Type ID: 5372
• Device Name: Device, Beam Limiting, X-ray, Diagnostic
• Regulation Description: Diagnostic X-ray Beam-limiting Device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.1610 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KPW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 12-296 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy
• 12-317 IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
  Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Radiography And Radioscopy [Including: Amendment 2 (2018)]

Total Product Life Cycle

• Device Type ID: 5372
• Device: Device, Beam Limiting, X-ray, Diagnostic
• Product Code: KPW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Diagnostic X-ray Beam-limiting Device.
• CFR Regulation Number: 892.1610 [🔎]

Device Problems
Detachment Of Device Or Device Component	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 21:05:05