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510(k) K253264

myAblation Guide (VC10A) by Siemens Healthcare GmbH — Product Code QTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2026
Date Received
September 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.

Other clearances by Siemens Healthcare GmbH

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  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)
  • K252608 — AI-Rad Companion Prostate MR (September 9, 2025)
  • K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobil (June 16, 2025)
  • K242551 — syngo Dynamics (Version VA41D) (April 3, 2025)
  • K242745 — AI-Rad Companion Organs RT (March 27, 2025)
  • K241770 — Prostate MR AI (VA10A) (March 5, 2025)
  • K240796 — myAblation Guide (VB80A) (August 6, 2024)

Other clearances for product code QTZ

  • K252947 — HistoSonics® Planning Tool (May 29, 2026)
  • K251931 — BioTraceIO Vision (V1.7) (September 8, 2025)
  • K240796 — myAblation Guide (VB80A) (August 6, 2024)
  • K240773 — VisAble.IO (April 15, 2024)
  • K222222 — Artemis, Artemis TPO, Artemis MX (October 12, 2023)
  • K222938 — Ablation-fit (September 12, 2023)
  • K223639 — VisAble.IO (August 28, 2023)
  • K220256 — MIM-Ablation (October 7, 2022)