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FDA 510(k) Application Details - K203195
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K203195
Device Name
System, Image Processing, Radiological
Applicant
Synopsys (Northern Europe) Ltd.
Bradninch Hall, Castle Street
Exeter EX4 3PL GB
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Contact
Jessica James
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
10/28/2020
Decision Date
04/01/2021
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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