QTZ

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Product code
QTZ
Device name
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device class
Class 2
21 CFR
21 CFR 892.2050
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
9

FDA classification definition

To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2026-06-16.

NumberDecision dateApplicantDevice nameSummary
K2532642026-06-16Siemens Healthcare GmbHmyAblation Guide (VC10A)FDA
K2529472026-05-29HistoSonics, Inc.HistoSonics® Planning ToolPDF
K2519312025-09-08Techsomed Medical TechnologiesBioTraceIO Vision (V1.7)PDF
K2407962024-08-06Siemens Healthcare GmbHmyAblation Guide (VB80A)PDF
K2407732024-04-15TechsomedVisAble.IOPDF
K2222222023-10-12EigenArtemis, Artemis TPO, Artemis MXPDF
K2229382023-09-12R.A.W. S.R.LAblation-fitPDF

6 summaries are archived here for direct download.

Official FDA classification page: QTZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).