Phantom, Flood Source, Nuclear

Device Code: 5331

Product Code(s): IYQ

Device Classification Information

Device Type ID5331
Device NamePhantom, Flood Source, Nuclear
Regulation DescriptionNuclear Flood Source Phantom.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1380 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIYQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5331
DevicePhantom, Flood Source, Nuclear
Product CodeIYQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNuclear Flood Source Phantom.
CFR Regulation Number892.1380 [🔎]
TPLC Last Update: 2019-04-02 21:04:28

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