Cassette, Radiographic Film

Device Code: 5302

Product Code(s): IXA

Device Classification Information

Device Type ID5302
Device NameCassette, Radiographic Film
Regulation DescriptionRadiographic Film Cassette.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1850 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIXA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5302
DeviceCassette, Radiographic Film
Product CodeIXA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRadiographic Film Cassette.
CFR Regulation Number892.1850 [🔎]
TPLC Last Update: 2019-04-02 21:03:58

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