Assembly, Tube Housing, X-ray, Diagnostic

Device Code: 5277

Product Code(s): ITY

Device Classification Information

• Device Type ID: 5277
• Device Name: Assembly, Tube Housing, X-ray, Diagnostic
• Regulation Description: Diagnostic X-ray Tube Housing Assembly.
• 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: 892.1760 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: ITY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-6 IEC 60806 First Edition 1984-01
  Determination Of The Maximum Symmetrical Radiation Field From A Rotating Anode X-Ray Tube For Medical Diagnosis
• 12-204 IEC 60601-2-28 Edition 2.0 2010-03
  Medical Electrical Equipment - Part 2-28: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Tube Assemblies For Medical Diagnosis
• 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
• 12-309 IEC 60601-2-28 Edition 3.0 2017-06
  Medical Electrical Equipment - Part 2-28: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Tube Assemblies For Medical Diagnosis
• 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: 5277
• Device: Assembly, Tube Housing, X-ray, Diagnostic
• Product Code: ITY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Diagnostic X-ray Tube Housing Assembly.
• CFR Regulation Number: 892.1760 [🔎]

TPLC Last Update: 2019-04-02 21:03:31