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510(k) Data Aggregation
K Number
K222625Device Name
Shield System
Manufacturer
Date Cleared
2022-09-30
(30 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Radiaction Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided-procedures with the Toshiba Infinix-I or Siemens Artis C-arm, by attenuation. It is not intended to be used with such procedures for head and neck areas.
Device Description
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K Number
K212159Device Name
Shield System
Manufacturer
Date Cleared
2022-03-30
(261 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Radiaction Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Radiaction's Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided procedures with the Toshiba Infinix-I C-arm, by attenuating scatter radiation. It is not intended to be used with such procedures for head and neck areas.
Device Description
Not Found
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