510(k) · Cleared
ClearedmyAblation Guide (VC10A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Jun 16, 2026 as substantially equivalent to K240796 (Siemens Healthcare GmbH, 2024) after a 260-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jun 16, 2026
- Review
- 260 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001284 (2000). 8 ancestors in all, the oldest K974513 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 5 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 4 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 3 generations backK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- 2 generations backK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- 1 generation backK240796 myAblation Guide (VB80A)Siemens Healthcare GmbH · 2024
- This deviceK253264 myAblation Guide (VC10A)Siemens Healthcare GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −5 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −4 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −3 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| −2 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| −1 | K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | 2024 | — |
| 0 (this device) | K253264 | myAblation Guide (VC10A) | Siemens Healthcare GmbH | 2026 | — |
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 |
|---|---|---|---|
| * | K240796 | myAblation Guide (VB80A)Summary page 5…ation Number: §892.2050 Medical image management and processing system Product Code QTZ III. Predicate Device: myAblation Guide (K240796) This predicate has not been subject to a design-related recall. IV. Subject Device Description: myAblation Gu… | 2024 |
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 26 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 8 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?
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation…
Read the full statement (146 words)
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities.
The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation.
The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment.
The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
myAblation Guide is not intended for use in neurological or cardiac applications and is not intended for pediatric patients (pediatric patients according to US Law 21 CFR 814.3(s)).
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/K253264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253264: myAblation Guide (VC10A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253264
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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