Test-pattern, Radiographic

Device Code: 5305

Product Code(s): IXF

Device Classification Information

Device Type ID5305
Device NameTest-pattern, Radiographic
Regulation DescriptionRadiologic Quality Assurance Instrument.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1940 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIXF
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5305
DeviceTest-pattern, Radiographic
Product CodeIXF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadiologic Quality Assurance Instrument.
CFR Regulation Number892.1940 [🔎]
TPLC Last Update: 2019-04-02 21:04:01

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