Home / 510(k) Clearances / K133643

510(k) K133643

SYNGO, CT LIVER ANALYSIS by Siemens Medi Cal Solutions, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
November 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Medi Cal Solutions, Inc.

  • K193216 — syngo.CT Lung CAD (March 9, 2020)
  • K182639 — MOBILETT Elara Max (March 15, 2019)
  • K182517 — MULTIX Impact (January 11, 2019)
  • K181279 — Ysio Max (June 13, 2018)
  • K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (April 2, 2018)
  • K173408 — Mammomat Revelation (March 21, 2018)
  • K172832 — Insight BD (February 6, 2018)
  • K171766 — Acuson SC2000 Diagnostic Ultrasound System (July 12, 2017)
  • K170315 — Acuson SC2000 Diagnostic Ultrasound System (April 4, 2017)
  • K162102 — MAGNETOM Avantofit, MAGNETOM Skyrafit (November 22, 2016)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • 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)