Cleared Traditional

K252947 - HistoSonics® Planning Tool (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252947 · HistoSonics, Inc. · Radiology device
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May 2026
Decision
256d
Days
Class 2
Risk

K252947 is an FDA 510(k) clearance for the HistoSonics® Planning Tool. Classified as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (product code QTZ), Class II - Special Controls.

Submitted by HistoSonics, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 29, 2026 after a review of 256 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all HistoSonics, Inc. devices

Submission Details

510(k) Number K252947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date May 29, 2026
Days to Decision 256 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 107d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

All 7
Devices cleared under the same product code (QTZ) and FDA review panel - the closest regulatory comparables to K252947.
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