# K240773: VisAble.IO

- Pathway: 510(k) (Special)
- Applicant: Techsomed
- Decided: Apr 15, 2024 after 25 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: 6 generations back to K001284 (2000). 8 ancestors in all.
1 later device descends 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)
- K223639: VisAble.IO, Techsomed (2023) Summary page 4.

## Most influential descendants
- K251931: BioTraceIO Vision  (V1.7) (2025), 0 descendants of its own

## Indications for use
VisAble.IO is a Computed Tomography (CT) and Magnetic Resonance (MR) 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 and MR scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning 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/K240773
Methodology: https://510kreport.com/methodology