# K251931: BioTraceIO Vision  (V1.7)

- Pathway: 510(k) (Traditional)
- Applicant: Techsomed Medical Technologies
- Decided: Sep 8, 2025 after 76 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: 7 generations back to K001284 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240773: VisAble.IO, Techsomed (2024) Summary page 5.

## Indications for use
BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. BioTraceIO Vision is controlled by the user via a user interface. BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures. BioTraceIO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTraceIO Vision 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/K251931
Methodology: https://510kreport.com/methodology