HistoSonics Planning Tool is a stand-alone visualization and comparison tool for CT and MR studies used to plan histotripsy target localization, treatment volume, acoustic path, and patient position.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
HistoSonics Planning Tool is a stand-alone visualization and comparison tool for CT and MR studies used to plan histotripsy target localization, treatment volume, acoustic path, and patient position.
FDA source Exact FDA submission Checked 2026-09-04
HistoSonics Planning Tool is a stand-alone visualization and comparison tool for CT and MR studies used to plan histotripsy target localization, treatment volume, acoustic path, and patient position.
FDA source Exact FDA submission Checked 2026-09-04
The FDA material states that the tool is not for diagnosis and does not interact or share data with the histotripsy therapy system; final planning remains with the treating team.
FDA source Exact FDA submission Checked 2026-09-04
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K252947
FDA source Exact FDA submission Checked 2026-08-31
Reviewed sources checked Exact FDA submission Checked 2026-09-04
Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Training and support
Use by the qualified healthcare professionals identified for the exact labeled workflow; site-specific competency and training requirements remain to be established locally.
FDA source Exact FDA submission Checked 2026-09-04
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The FDA material states that the tool is not for diagnosis and does not interact or share data with the histotripsy therapy system; final planning remains with the treating team.
exact submission · checked 2026-09-04
Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04
No exact-product price was found in the evidence set; productivity or value claims require local evidence.
Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.
exact submission · checked 2026-09-04
Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
The exact FDA decision material describes the labeled intended use and submission-level verification for this release. It does not establish a product-wide clinical sensitivity or specificity claim or independent clinical outcome evidence.
FDA source Exact FDA submission Checked 2026-09-04
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No exact-product, version-specific sensitivity endpoint was established for this submission in the evidence set.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K252947 FDA evidence package for HistoSonics® Planning Tool
FDA submission-level decision material with device, software, performance, safety, and/or usability verification as applicable; not independent clinical validation. · Population and workflow are limited to the exact FDA labeling summarized for this submission.
exact submission · Tested version: Exact FDA submission release; version not separately stated in the public decision material · Sponsor or vendor study
K252947
Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, dental, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K252947 by native exact submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-04
Exact-identifier review does not prove absence of all product-family safety signals.
Verify security and privacy controls: Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Verify pricing and total cost: No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
Verify local validation and lifecycle monitoring: Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
9Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA decision material was reviewed for identity and labeled use. Optional literature, trial, and recall candidates were not promoted without exact product or version applicability; commercial, security, and performance claims remain unknown where not established. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
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