System, Simulation, Radiation Therapy

Device Code: 5368

Product Code(s): KPQ

Device Classification Information

• Device Type ID: 5368
• Device Name: System, Simulation, Radiation Therapy
• Regulation Description: Radiation Therapy Simulation System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.5840 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KPQ
• 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

• 12-211 IEC 60601-2-29 Edition 3.0 2008-06
  Medical Electrical Equipment - Part 2-29: Particular Requirements For The Basic Safety And Essential Performance Of Radiotherapy Simulators
• 12-259 IEC 61674 Edition 2.0 2012-11
  Medical Electrical Equipment -- Dosimeters With Ionization Chambers And/or Semiconductor Detectors As Used In X-ray Diagnostic Imaging
• 12-267 IEC 61217 Edition 2.0 2011-12
  Radiotherapy Equipment - Coordinates, Movements, And Scales

Total Product Life Cycle

• Device Type ID: 5368
• Device: System, Simulation, Radiation Therapy
• Product Code: KPQ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Radiation Therapy Simulation System.
• CFR Regulation Number: 892.5840 [🔎]

Premarket Reviews
Manufacturer	Decision
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Use Of Device Problem	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Medical Solutions USA, Inc	II	Jan-17-2014
2	Siemens Medical Solutions USA, Inc	II	Nov-20-2014

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