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FDA 510(k) Application Details - K982535
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K982535
Device Name
System, Image Processing, Radiological
Applicant
NEO IMAGERY TECHNOLOGIES, INC.
16303 PANORAMIC WAY
SAN LEANDRO, CA 94578-1116 US
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Contact
GARY J ALLSEBROOK
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/1998
Decision Date
12/21/1998
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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