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FDA 510(k) Application Details - K193216
Device Classification Name
Lung Computed Tomography System, Computer-Aided Detection
More FDA Info for this Device
510(K) Number
K193216
Device Name
Lung Computed Tomography System, Computer-Aided Detection
Applicant
Siemens Medical Solutions, Inc
65 Valley Stream Parkway
Malvern, PA 19355 US
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Contact
Abhineet Johri
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
OEB
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More FDA Info for this Product Code
Date Received
11/21/2019
Decision Date
03/09/2020
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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