510(k) · Cleared
ClearedAblation-fit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R.a.W. S.R.L · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Sep 12, 2023 as substantially equivalent to K202297 (Mirada Medical, Ltd., 2020) after a 351-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Sep 12, 2023
- Review
- 351 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001284 (2000). 7 ancestors in all, the oldest K974513 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 4 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 3 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 2 generations backK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- 1 generation backK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- This deviceK222938 Ablation-fitR.a.W. S.R.L · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −4 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −3 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −2 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| −1 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| 0 (this device) | K222938 | Ablation-fit | R.a.W. S.R.L | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 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 K252947 HistoSonics® Planning Toolscore 14.4 · 11 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 |
|---|---|---|---|
| * | K202297 | Aline Ablation IntelligenceSummary page 4…cate device: • Aline Ablation Intelligence - Class II – 21 CFR 892.2050, Radiology, LLZ, which has been the subject of a cleared 510(k) with the FDA log number K202297. 510(k) Number K202297 Trade Name Aline Ablation Intelligence Manufacturer M… | 2020 |
| † | K212896 | Visible Patient Suite | 2021 |
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 23 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K202297.
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. 2023, 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?
Ablation-fit is a medical imaging application available for use with liver ablation procedures.
Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.
Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222938: Ablation-fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222938
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026