Collimator, X-ray

Device Code: 5256

Product Code(s): EHB

Device Classification Information

Device Type ID5256
Device NameCollimator, X-ray
Regulation DescriptionDental X-ray Position Indicating Device.
Regulation Medical SpecialtyDental
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number872.1840 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEHB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5256
DeviceCollimator, X-ray
Product CodeEHB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental X-ray Position Indicating Device.
CFR Regulation Number872.1840 [🔎]
Device Problems
Device Operational Issue
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:03:10

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