Processor, Radiographic-film, Automatic, Dental

Device Code: 5274

Product Code(s): EGY

Device Classification Information

Device Type ID5274
Device NameProcessor, Radiographic-film, Automatic, Dental
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 CodeEGY
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 ID5274
DeviceProcessor, Radiographic-film, Automatic, Dental
Product CodeEGY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAutomatic Radiographic Film Processor.
CFR Regulation Number892.1900 [🔎]
TPLC Last Update: 2019-04-02 21:03:28

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