Scanner, Rectilinear, Nuclear

Device Code: 5333

Product Code(s): IYW

Device Classification Information

Device Type ID5333
Device NameScanner, Rectilinear, Nuclear
Regulation DescriptionNuclear Rectilinear Scanner.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1300 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIYW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5333
DeviceScanner, Rectilinear, Nuclear
Product CodeIYW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNuclear Rectilinear Scanner.
CFR Regulation Number892.1300 [🔎]
TPLC Last Update: 2019-04-02 21:04:30

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