Generator, Orthovoltage, Therapeutic X-ray

Device Code: 5319

Product Code(s): IYC

Device Classification Information

Device Type ID5319
Device NameGenerator, Orthovoltage, Therapeutic X-ray
Regulation DescriptionX-ray Radiation Therapy System.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.5900 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIYC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID5319
DeviceGenerator, Orthovoltage, Therapeutic X-ray
Product CodeIYC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionX-ray Radiation Therapy System.
CFR Regulation Number892.5900 [🔎]
Device Problems
Material Rupture
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:04:15

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