System, X-ray, Tomographic

Device Code: 5339

Product Code(s): IZF

Device Classification Information

Device Type ID5339
Device NameSystem, X-ray, Tomographic
Regulation DescriptionTomographic X-ray System.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.1740 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIZF
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 ID5339
DeviceSystem, X-ray, Tomographic
Product CodeIZF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTomographic X-ray System.
CFR Regulation Number892.1740 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Philips Electronics North America Corporation
II Sep-21-2018
TPLC Last Update: 2019-04-02 21:04:36

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