Phantom, Anthropomorphic, Nuclear

Device Code: 5330

Product Code(s): IYP

Device Classification Information

Device Type ID5330
Device NamePhantom, Anthropomorphic, Nuclear
Regulation DescriptionNuclear Anthropomorphic Phantom.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1370 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIYP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5330
DevicePhantom, Anthropomorphic, Nuclear
Product CodeIYP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNuclear Anthropomorphic Phantom.
CFR Regulation Number892.1370 [🔎]
TPLC Last Update: 2019-04-02 21:04:27

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