510(k) · Cleared
ClearedHistoSonics® Planning Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HistoSonics, Inc. · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on May 29, 2026 as substantially equivalent to K192038 (Covidien, LLC, 2019) after a 256-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- May 29, 2026
- Review
- 256 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954678 (1996). 23 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK142048 Emprint Procedure Planning ApplicationCovidien, LLC · 2014
- 2 generations backK180192 Emprint Ablation Visualization ApplicationCovidien, LLC · 2018
- 1 generation backK192038 Emprint Visualization ApplicationCovidien, LLC · 2019
- This deviceK252947 HistoSonics® Planning ToolHistoSonics, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 7 generations backK053155 VimplantCybermed, Inc. · 2005
- 6 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 5 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 4 generations backK140093 TABLEAnatomage, Inc. · 2014
- 3 generations backK142048 Emprint Procedure Planning ApplicationCovidien, LLC · 2014
- 2 generations backK180192 Emprint Ablation Visualization ApplicationCovidien, LLC · 2018
- 1 generation backK192038 Emprint Visualization ApplicationCovidien, LLC · 2019
- This deviceK252947 HistoSonics® Planning ToolHistoSonics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −7 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −6 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −5 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −4 | K140093 | TABLE | Anatomage, Inc. | 2014 | — |
| −3 | K142048 | Emprint Procedure Planning Application | Covidien, LLC | 2014 | — |
| −2 | K180192 | Emprint Ablation Visualization Application | Covidien, LLC | 2018 | — |
| −1 | K192038 | Emprint Visualization Application | Covidien, LLC | 2019 | — |
| 0 (this device) | K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QTZ device
- #1 K220256 MIM-Ablationscore 14.3 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192038 | Emprint Visualization ApplicationSummary page 5…Medicine (DICOM) Standard 3. Predicate Device Device Name: Emprint Visualization System 510(k): K192038 Device Common Name: DICOM Viewer Regulation Number: 21 CFR Part 892.2050 Regulatory Description: Medical… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
How does its category compare?
All QTZ devicesQTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QTZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QTZ
351in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QTZ
No recall names QTZ since 2007.
Adverse event reports per year · QTZ
No MAUDE report names QTZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 351 | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The HistoSonics Planning Tool is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in histotripsy procedures conducted using HistoSonics Histotripsy Systems. The software is not intended for diagnosis. The software is used to evaluate images in the region of interest for patients deemed suitable for histotripsy by the treating physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252947: HistoSonics® Planning Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252947
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026