Generator, Dermatological (grenz Ray), Therapeutic X-ray

Device Code: 5323

Product Code(s): IYH

Device Classification Information

Device Type ID5323
Device NameGenerator, Dermatological (grenz Ray), 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 CodeIYH
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 ID5323
DeviceGenerator, Dermatological (grenz Ray), Therapeutic X-ray
Product CodeIYH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionX-ray Radiation Therapy System.
CFR Regulation Number892.5900 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Brainlab AG
II May-06-2015
TPLC Last Update: 2019-04-02 21:04:19

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