myAblation Guide (VC10A)— 510(k) K253264

Name: FDA 510(k) clearance K253264
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K253264 for myAblation Guide (VC10A), Substantially Equivalent on 2026-06-16. Applicant: Siemens Healthcare GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Code QTZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlanger, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QTZ

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K240773 — VisAble.IO2024-04-15
K222222 — Artemis, Artemis TPO, Artemis MX2023-10-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.