# K223639: VisAble.IO

- Pathway: 510(k) (Traditional)
- Applicant: Techsomed
- Decided: Aug 28, 2023 after 266 days
- Product code: QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation)
- 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: 5 generations back to K001284 (2000). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202297: Aline Ablation Intelligence, Mirada Medical, Ltd. (2020) Summary page 4.

## Most influential descendants
- K240773: VisAble.IO (2024), 1 descendant of its own
- K251931: BioTraceIO Vision  (V1.7) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K223639
Methodology: https://510kreport.com/methodology