510(k) · Cleared
ClearedAline Ablation Intelligence
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirada Medical, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 11, 2020 as substantially equivalent to K150313 (Neuwave Medical, Inc., 2015) after a 29-day review. Its family tree reaches back 4 generations to 2000. 11 later devices descend from it.
- Decided
- Sep 11, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001284 (2000). 6 ancestors in all, the oldest K974513 (1998). 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 3 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 2 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 1 generation backK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- This deviceK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK220256 MIM-AblationMim Software, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK232862 MIM – Monte Carlo DosimetryMim Software, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK223639 VisAble.IOTechsomed · 2023
- Descendant · 3 generations on · 1 of its ownK243012 MIM – Symphony HDR FusionMim Software, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK240796 myAblation Guide (VB80A)Siemens Healthcare GmbH · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K220256MIM-AblationMim Software, Inc. · 2022 · cites it directly4descendants
- K232862MIM – Monte Carlo DosimetryMim Software, Inc. · 2024 · 2 generations on2descendants
- K223639VisAble.IOTechsomed · 2023 · cites it directly2descendants
- K243012MIM – Symphony HDR FusionMim Software, Inc. · 2024 · 3 generations on1descendant
- K240796myAblation Guide (VB80A)Siemens Healthcare GmbH · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −3 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −2 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −1 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| 0 (this device) | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| +1 | K220256 | MIM-Ablation | Mim Software, Inc. | 2022 | — |
| +2 | K232862 | MIM – Monte Carlo Dosimetry | Mim Software, Inc. | 2024 | — |
| +1 | K223639 | VisAble.IO | Techsomed | 2023 | — |
| +3 | K243012 | MIM – Symphony HDR Fusion | Mim Software, Inc. | 2024 | — |
| +1 | K240796 | myAblation Guide (VB80A) | Siemens Healthcare GmbH | 2024 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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 |
|---|---|---|---|
| * | K150313 | Ablation ConfirmationSummary page 4…ystem. Regulatory Class Class II Primary Product Code LLZ Predicate Device 510(k) Number K150313 Trade Name Ablation Confirmation (AC) Manufacturer NeuWave Medical, Inc. Device Name… | 2015 |
| † | K102687 | Mirada RT | 2010 |
| † | K130393 | Mirada RTX | 2013 |
| † | K101228 | Mirada XD | 2010 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K220256 (Mim Software, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K150313.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. Aline Ablation Intelligence is controlled by the user via a user interface on a workstation. Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures. Aline Ablation Intelligence is used to assist…
Read the full statement (111 words)
Aline Ablation Intelligence is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
Aline Ablation Intelligence is controlled by the user via a user interface on a workstation.
Aline Ablation Intelligence imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
Aline Ablation Intelligence is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. Aline Ablation Intelligence 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/K202297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202297: Aline Ablation Intelligence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202297
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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