Bed, Scanning, Nuclear

Device Code: 5336

Product Code(s): IYZ

Device Classification Information

Device Type ID5336
Device NameBed, Scanning, Nuclear
Regulation DescriptionNuclear Scanning Bed.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1350 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIYZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5336
DeviceBed, Scanning, Nuclear
Product CodeIYZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNuclear Scanning Bed.
CFR Regulation Number892.1350 [🔎]
TPLC Last Update: 2019-04-02 21:04:32

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