myAblation Guide (VC10A)— 510(k) K253264
Substantially EquivalentSiemens Healthcare GmbH
FDA 510(k) clearance K253264 for myAblation Guide (VC10A), Substantially Equivalent on 2026-06-16. Applicant: Siemens Healthcare GmbH. Device class: 2.
Summary
Siemens Healthcare's myAblation Guide (VC10A) is filed under QTZ, radiological image processing software for ablation therapy planning and evaluation. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens Healthcare filed from Erlanger, Germany, as the record spells the city. Review took 260 calendar days (September 29, 2025 to June 16, 2026).
Clearance details
- Applicant
- Siemens Healthcare GmbH
- Product code
- Product code QTZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlanger, DE
Recent devices under product code QTZ
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