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FDA 510(k) Application Details - K951942
Device Classification Name
Device, Digital Image Storage, Radiological
More FDA Info for this Device
510(K) Number
K951942
Device Name
Device, Digital Image Storage, Radiological
Applicant
INSIGHT SYSTEMS
14 SUNSET RIDGE DR.
POMONA, CA 91766 US
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Contact
DONALD R MAXWELL
Other 510(k) Applications for this Contact
Regulation Number
892.2010
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Classification Product Code
LMB
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More FDA Info for this Product Code
Date Received
04/26/1995
Decision Date
04/08/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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