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510(k) K073373

SYNGO VOLUME PERFUSION-CT BODY by Siemens AG Medical Solutions — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2007
Date Received
December 3, 2007
Clearance Type
Abbreviated
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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  • K101666 — SYNGO. PLAZA VA20A (August 10, 2010)
  • K100637 — SYNGO.CT CORONARY ANALYSIS (May 26, 2010)
  • K093612 — SYNGO.PLAZA (March 4, 2010)
  • K092067 — ABVS WORKPLACE (September 18, 2009)
  • K092519 — SYNGO.X (August 27, 2009)

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