Phantom, Test-pattern, Radionuclide

Device Code: 5365

Product Code(s): JAR

Device Classification Information

Device Type ID5365
Device NamePhantom, Test-pattern, Radionuclide
Regulation DescriptionRadionuclide Test Pattern Phantom.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1420 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJAR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5365
DevicePhantom, Test-pattern, Radionuclide
Product CodeJAR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadionuclide Test Pattern Phantom.
CFR Regulation Number892.1420 [🔎]
TPLC Last Update: 2019-04-02 21:04:59

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