MIM-Ablation
FDA 510(k) K220256 · Mim Software, Inc.
510(k) numberK220256
Submission
- Device name
- MIM-Ablation
- Applicant
- Mim Software, Inc.
Beachwood, OH, US - Received
- January 31, 2022
- Decision date
- October 7, 2022
- 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 |
| K222938 | Ablation-fitQTZ · Traditional | R.A.W. S.R.L | 09/12/2023SE |
| K223639 | VisAble.IOQTZ · Traditional | Techsomed | 08/28/2023SE |
More from Techsomed
| 510(k) | Device | Decision |
|---|---|---|
| K253270 | Contour ProtégéAI+QKB · Traditional | 03/27/2026SE |
| K251883 | MIM LesionID ProLLZ · Traditional | 12/11/2025SE |
| K250035 | Contour ProtégéAI+QKB · Special | 02/03/2025SE |
| K243012 | MIM Symphony HDR FusionLLZ · Special | 10/23/2024SE |
| K233620 | MIM - Centiloid ScalingLLZ · Traditional | 05/20/2024SE |
| K232862 | MIM Monte Carlo DosimetryLLZ · Traditional | 05/13/2024SE |
| K232514 | MIM Dose AnalysisLLZ · Traditional | 05/06/2024SE |
| K231765 | Contour ProtégéAIQKB · Special | 11/08/2023SE |
| K223774 | Contour ProtégéAIQKB · Traditional | 04/06/2023SE |
| K223800 | MIM Additional TracersLLZ · Special | 01/17/2023SE |
Questions and answers
When was MIM-Ablation cleared by the FDA?
MIM-Ablation (K220256) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 249 days after the submission was received.
What is the product code of K220256?
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.