Cleared Traditional

myAblation Guide (VB80A)

K240796 · Siemens Healthcare GmbH · Radiology

Aug 2024

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K240796 is an FDA 510(k) clearance for the myAblation Guide (VB80A), a Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (Class II — Special Controls, product code QTZ), submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on August 6, 2024, 137 days after receiving the submission on March 22, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K240796 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2024
Decision Date	August 06, 2024
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QTZ — Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.