Phantom, Anthropomorphic, Radiographic

Device Code: 5306

Product Code(s): IXG

Device Classification Information

Device Type ID5306
Device NamePhantom, Anthropomorphic, Radiographic
Regulation DescriptionRadiographic Anthropomorphic Phantom.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1950 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIXG
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5306
DevicePhantom, Anthropomorphic, Radiographic
Product CodeIXG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadiographic Anthropomorphic Phantom.
CFR Regulation Number892.1950 [🔎]
TPLC Last Update: 2019-04-02 21:04:01

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