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FDA 510(k) Application Details - K172531
Device Classification Name
More FDA Info for this Device
510(K) Number
K172531
Device Name
Biograph mMR with mMR Angio Transfer Option
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355 US
Other 510(k) Applications for this Company
Contact
Cordell L. Fields
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/22/2017
Decision Date
11/14/2017
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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