510(k) · Cleared
ClearedVisAble.IO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techsomed · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Aug 28, 2023 as substantially equivalent to K202297 (Mirada Medical, Ltd., 2020) after a 266-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 28, 2023
- Review
- 266 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). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK223639 VisAble.IOTechsomed · 2023
- Descendant · cites it directly · 1 of its ownK240773 VisAble.IOTechsomed · 2024
- Descendant · 2 generations on · 0 of its ownK251931 BioTraceIO Vision (V1.7)Techsomed Medical Technologies · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K223639 | VisAble.IO | Techsomed | 2023 | — |
| +1 | K240773 | VisAble.IO | Techsomed | 2024 | — |
| +2 | K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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…d Processing System (21 CFR 892.2050) Regulatory Class: Class II Product Code: QTZ, QIH, LLZ Predicate Devices 510(k) Number K202297 Trade Name Aline Ablation Intelligence Manufacturer… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240773 | VisAble.IO | 2024 | 1 |
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.
- Of its descendants, K240773 (Techsomed, 2024) has gone furthest, with 1 descendant of its own.
- 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?
VisAble.IO is a Computed Tomography (CT) image processing software package available for use
with liver ablation procedures.
VisAble.IO is controlled by the user via a user interface.
VisAble.IO imports images from CT scanners and facility PACS systems for display and processing
during liver ablation planning.
VisAble.IO is used to assist physicians in planning liver ablation procedures, including identifying
ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in
confirming ablation zones.
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/K223639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223639: VisAble.IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223639
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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