Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162483
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K162483
Device Name
System, Tomography, Computed, Emission
Applicant
SIEMENS MEDICAL SOLUTIONS, USA, INC.
2501 N. BARRINGTON ROAD
Hoffman Estates, IL 60192-2061 US
Other 510(k) Applications for this Company
Contact
Cynthia Busch
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2016
Decision Date
01/09/2017
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact