Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
FDA product code QTZ · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253264 | myAblation Guide (VC10A)QTZ · Traditional | Siemens Healthcare GmbH | 06/16/2026SE |
| K252947 | HistoSonics® Planning ToolQTZ · Traditional | HistoSonics, Inc. | 05/29/2026SE |
| K251931 | BioTraceIO Vision (V1.7)QTZ · Traditional | Techsomed Medical Technologies | 09/08/2025SE |
| K240796 | myAblation Guide (VB80A)QTZ · Traditional | Siemens Healthcare GmbH | 08/06/2024SE |
| K240773 | VisAble.IOQTZ · Special | Techsomed | 04/15/2024SE |
| K222222 | Artemis, Artemis TPO, Artemis MXQTZ · Traditional | Eigen | 10/12/2023SE |
| K222938 | Ablation-fitQTZ · Traditional | R.A.W. S.R.L | 09/12/2023SE |
| K223639 | VisAble.IOQTZ · Traditional | Techsomed | 08/28/2023SE |
| K220256 | MIM-AblationQTZ · Traditional | Mim Software, Inc. | 10/07/2022SE |