Holder, Head, Radiographic

Device Code: 5300

Product Code(s): IWY

Device Classification Information

Device Type ID5300
Device NameHolder, Head, Radiographic
Regulation DescriptionRadiographic Head Holder.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1920 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIWY
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5300
DeviceHolder, Head, Radiographic
Product CodeIWY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadiographic Head Holder.
CFR Regulation Number892.1920 [🔎]
TPLC Last Update: 2019-04-02 21:03:55

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