System, X-ray, Fluoroscopic, Non-image-intensified

Device Code: 5353

Product Code(s): JAB

Device Classification Information

Device Type ID5353
Device NameSystem, X-ray, Fluoroscopic, Non-image-intensified
Regulation DescriptionNon-image-intensified Fluoroscopic X-ray System.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.1660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJAB
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 ID5353
DeviceSystem, X-ray, Fluoroscopic, Non-image-intensified
Product CodeJAB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNon-image-intensified Fluoroscopic X-ray System.
CFR Regulation Number892.1660 [🔎]
TPLC Last Update: 2019-04-02 21:04:48

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