# K222938: Ablation-fit

- Pathway: 510(k) (Traditional)
- Applicant: R.a.W. S.R.L
- Decided: Sep 12, 2023 after 351 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.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
Ablation-fit is a medical imaging application available for use with liver ablation procedures. Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement. Ablation-fit is used to assist physicians in confirming ablation zones during follow-up. 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/K222938
Methodology: https://510kreport.com/methodology