Processor, Cine Film

Device Code: 5316

Product Code(s): IXX

Device Classification Information

Device Type ID5316
Device NameProcessor, Cine Film
Regulation DescriptionAutomatic Radiographic Film Processor.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1900 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIXX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID5316
DeviceProcessor, Cine Film
Product CodeIXX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAutomatic Radiographic Film Processor.
CFR Regulation Number892.1900 [🔎]
TPLC Last Update: 2019-04-02 21:04:12

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