Illuminator, Radiographic-film

Device Code: 5303

Product Code(s): IXC

Device Classification Information

Device Type ID5303
Device NameIlluminator, Radiographic-film
Regulation DescriptionRadiographic Film Illuminator.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1890 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIXC
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5303
DeviceIlluminator, Radiographic-film
Product CodeIXC
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadiographic Film Illuminator.
CFR Regulation Number892.1890 [🔎]
TPLC Last Update: 2019-04-02 21:03:58

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