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FDA 510(k) Application Details - K161559
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K161559
Device Name
System, Image Processing, Radiological
Applicant
4QIMAGING, LLC DBA QMETRICS
1250 PITTSFORD-VICTOR RD.,
SUITE 110, BLDG.200
PITTSFORD, NY 14534 US
Other 510(k) Applications for this Company
Contact
EDWARD SCHREYER
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
06/06/2016
Decision Date
06/23/2016
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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