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FDA 510(k) Application Details - K170167
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K170167
Device Name
System, Image Processing, Radiological
Applicant
EchoPixel Inc.
2490 Hospital Drive, Suite 310
Mountain View, CA 94040 US
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Contact
Sergio Aguirre
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
01/19/2017
Decision Date
03/03/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
Y
Expedited Review
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