myAblation Guide (VB80A)— 510(k) K240796

Name: FDA 510(k) clearance K240796
Creator: U.S. Food and Drug Administration
Published: 2024-08-06

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K240796 for myAblation Guide (VB80A), Substantially Equivalent on 2024-08-06. 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: 2024-03-22
Decision date: 2024-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlanger, DE

Download summary PDF View on FDA.gov ↗

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