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510(k) K233753

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2024
Date Received
November 22, 2023
Clearance Type
Abbreviated
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

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  • K240796 — myAblation Guide (VB80A) (August 6, 2024)
  • K240294 — Syngo Carbon Enterprise Access (VA40A) (May 23, 2024)
  • K232744 — syngo Virtual Cockpit (VB10A) (December 21, 2023)

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  • 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)