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510(k) K252947

HistoSonics® Planning Tool by HistoSonics, Inc. — Product Code QTZ

K252947 is an FDA 510(k) premarket notification submitted by HistoSonics, Inc. for the device "HistoSonics® Planning Tool". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation), a Class II device regulated under 21 CFR 892.2050. HistoSonics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
September 15, 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 HistoSonics, Inc.

  • K241902 — Edison System (October 30, 2024)
  • K233466 — Edison System (March 13, 2024)
  • DEN220087 — Edison System (October 6, 2023)

Other clearances for product code QTZ

  • K253264 — myAblation Guide (VC10A) (June 16, 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)

FDA data resources