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FDA 510(k) Application Details - K222757
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K222757
Device Name
System, Image Processing, Radiological
Applicant
Clarus Viewer Corporation
5030 Bradford Drive NW; Building 2, Suite 104
Huntsville, AL 35805 US
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Contact
Steve Thomas
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
09/12/2022
Decision Date
02/24/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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