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510(k) K063762

SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY by Siemens AG Medical Solutions — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2007
Date Received
December 20, 2006
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

Other clearances by Siemens AG Medical Solutions

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  • K120331 — SYNGO CT DYNAMIC ANGIO (April 13, 2012)
  • K111079 — SYNGO.VIA WEB VIEWER (May 13, 2011)
  • 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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  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)