Cradle, Patient, Radiologic

Device Code: 5377

Product Code(s): KXH

Device Classification Information

Device Type ID5377
Device NameCradle, Patient, Radiologic
Regulation DescriptionRadiologic Patient Cradle.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number892.1830 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKXH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5377
DeviceCradle, Patient, Radiologic
Product CodeKXH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRadiologic Patient Cradle.
CFR Regulation Number892.1830 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Med Tec Inc
II Aug-29-2017
TPLC Last Update: 2019-04-02 21:05:09

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