# K202297: Aline Ablation Intelligence

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Medical, Ltd.
- Decided: Sep 11, 2020 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001284 (2000). 6 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150313: Ablation Confirmation, Neuwave Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K220256: MIM-Ablation (2022), 4 descendants of its own
- K232862: MIM – Monte Carlo Dosimetry (2024), 2 descendants of its own
- K223639: VisAble.IO (2023), 2 descendants of its own
- K243012: MIM – Symphony HDR Fusion (2024), 1 descendant of its own
- K240796: myAblation Guide (VB80A) (2024), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K202297
Methodology: https://510kreport.com/methodology