Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
The Radiological Image Processing Software for Ablation Therapy Planning and Evaluation is a software device that provides radiological image processing tools to assist clinicians in the planning, monitoring, and post-procedure evaluation of ablation therapy for tumors or other target tissues. It integrates with imaging systems to support accurate treatment delivery and outcome assessment. Classified as FDA Class 2 under regulation 892.2050, it requires 510(k) clearance in the Radiology specialty. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTZ
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | Jun 16, 2026 | Substantially Equivalent | Siemens Healthcare GmbH |
| K252947 | HistoSonics® Planning Tool | May 29, 2026 | Substantially Equivalent | HistoSonics, Inc. |
| K251931 | BioTraceIO Vision (V1.7) | Sep 08, 2025 | Substantially Equivalent | Techsomed Medical Technologies |
| K240796 | myAblation Guide (VB80A) | Aug 06, 2024 | Substantially Equivalent | Siemens Healthcare GmbH |
| K240773 | VisAble.IO | Apr 15, 2024 | Substantially Equivalent | Techsomed |
| K222222 | Artemis, Artemis TPO, Artemis MX | Oct 12, 2023 | Substantially Equivalent | Eigen |
| K222938 | Ablation-fit | Sep 12, 2023 | Substantially Equivalent | R.A.W. S.R.L |
| K223639 | VisAble.IO | Aug 28, 2023 | Substantially Equivalent | Techsomed |
| K220256 | MIM-Ablation | Oct 07, 2022 | Substantially Equivalent | Mim Software, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.