# K253264: myAblation Guide (VC10A)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Jun 16, 2026 after 260 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.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240796: myAblation Guide (VB80A), Siemens Healthcare GmbH (2024) Summary page 5.

## Indications for use
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success. myAblation Guide is not intended for use in neurological or cardiac applications and is not intended for pediatric patients (pediatric patients according to US Law 21 CFR 814.3(s)).

Source page: https://510kreport.com/device/K253264
Methodology: https://510kreport.com/methodology