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FDA 510(k) Application Details - K051813
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K051813
Device Name
System, Image Processing, Radiological
Applicant
ULTRARAD CORPORATION
1600 MANCHESTER WAY
CORINTH, TX 76210 US
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Contact
CARL ALLETTO
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
07/05/2005
Decision Date
08/15/2005
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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