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510(k) K100637

SYNGO.CT CORONARY ANALYSIS by Siemens AG Medical Solutions — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2010
Date Received
March 5, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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