Generator, High-voltage, X-ray, Diagnostic

Device Code: 5345

Product Code(s): IZO

Device Classification Information

• Device Type ID: 5345
• Device Name: Generator, High-voltage, X-ray, Diagnostic
• Regulation Description: Diagnostic X-ray High Voltage Generator.
• 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: 892.1700 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IZO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-230 NEMA XR 24-2008 (R2014)
  Primary User Controls For Interventional Angiography X-ray Equipment
• 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
• 12-296 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: 5345
• Device: Generator, High-voltage, X-ray, Diagnostic
• Product Code: IZO
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Diagnostic X-ray High Voltage Generator.
• CFR Regulation Number: 892.1700 [🔎]

Device Problems
Device Operational Issue	2
Use Of Device Problem	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Shimadzu Medical Systems	II	Dec-23-2016

TPLC Last Update: 2019-04-02 21:04:42