myAblation Guide VB80A
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- myAblation Guide EUDAMED
- Device Name
- MDR_VT_IIb_ERLN_H_127_CTH_P10_Application Software EUDAMED
- Model / Reference
- MDR_VT_IIb_ERLN_H_127_CTH_P10_Application Software EUDAMED10831373 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869991771 EUDAMED
- Basic UDI-DI
- 0405686902238VL EUDAMED
- 510(k) Number
- K240796 FDA 510(k)
- FDA Product Code
- QTZ FDA 510(k)
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The myAblation Guide VB80A is a Radiological Image Processing Software designed for ablation therapy planning and evaluation. It integrates with imaging systems to assist in the precise planning, simulation, and assessment of microwave and cryoablation procedures, ensuring accurate tumor targeting and coverage.
This software is supplied as a Class II medical device under 21 CFR 892.2050, with FDA 510(k) clearance and MDR compliance. It is intended for use in radiology settings, supporting real-time procedural guidance and post-procedural analysis. The device operates on standard IT infrastructure and requires no physical sterilization, as it is non-invasive and software-based.
Frequently asked questions
What is the myAblation Guide VB80A used for?
The myAblation Guide VB80A is a radiological image processing software designed for ablation therapy planning and evaluation, helping with precise planning, simulation, and assessment of microwave and cryoablation procedures.
How is the myAblation Guide VB80A supplied?
The device is supplied as software that integrates with imaging systems and operates on standard IT infrastructure, requiring no physical sterilization as it is non-invasive.
What regulatory approvals does the myAblation Guide VB80A have?
The device has FDA 510(k) clearance and MDR compliance, classified as a Class II medical device under 21 CFR 892.2050.
In what settings is the myAblation Guide VB80A intended to be used?
It is intended for use in radiology settings, supporting real-time procedural guidance and post-procedural analysis for ablation therapies.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: myAblation Guide - Siemens Healthineers, PDF Siemens Healthcare GmbH ℅ Lynn Allman Senior Director, Regulatory ..., K240796 FDA 510 (k) - myAblation Guide (VB80A)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K240796 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K240796 24 fields · synced Oct 6, 2026
- EUDAMED 639b8160-5be4-4769-85e8-048985c2c845 61 fields · synced Jul 15, 2026