Ablation-fit
FDA 510(k) K222938 · R.A.W. S.R.L
510(k) numberK222938
Submission
- Device name
- Ablation-fit
- Applicant
- R.A.W. S.R.L
Milan, IT - Received
- September 26, 2022
- Decision date
- September 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QTZ – Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Other 510(k)s with product code QTZ
| 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 |
| K223639 | VisAble.IOQTZ · Traditional | Techsomed | 08/28/2023SE |
| K220256 | MIM-AblationQTZ · Traditional | Mim Software, Inc. | 10/07/2022SE |
Questions and answers
When was Ablation-fit cleared by the FDA?
Ablation-fit (K222938) received a 510(k) decision of Substantially Equivalent on September 12, 2023, 351 days after the submission was received.
What is the product code of K222938?
The FDA product code is QTZ – Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 892.2050.