myAblation Guide (VC10A)

Q: What is the product code of K253264?

The FDA product code is QTZ – Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 892.2050.

FDA 510(k) K253264 · Siemens Healthcare GmbH

Substantially Equivalent

510(k) numberK253264

Submission

Device name: myAblation Guide (VC10A)
Applicant: Siemens Healthcare GmbH
Erlanger, DE
Received: September 29, 2025
Decision date: June 16, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QTZ – Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2050
Specialty: Radiology

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

Other 510(k)s with product code QTZ

510(k)	Device	Applicant	Decision
K252947	HistoSonics® Planning ToolQTZ · Traditional	HistoSonics, Inc.	05/29/2026SE
K251931	BioTraceIO Vision (V1.7)QTZ · Traditional	Techsomed Medical Technologies	09/08/2025SE
K240796	myAblation Guide (VB80A)QTZ · Traditional	Siemens Healthcare GmbH	08/06/2024SE
K240773	VisAble.IOQTZ · Special	Techsomed	04/15/2024SE
K222222	Artemis, Artemis TPO, Artemis MXQTZ · Traditional	Eigen	10/12/2023SE
K222938	Ablation-fitQTZ · Traditional	R.A.W. S.R.L	09/12/2023SE
K223639	VisAble.IOQTZ · Traditional	Techsomed	08/28/2023SE
K220256	MIM-AblationQTZ · Traditional	Mim Software, Inc.	10/07/2022SE

More from Mim Software, Inc.

510(k)	Device	Decision
K253689	syngo Dynamics (VA41F)QIH · Traditional	04/10/2026SE
K252548	AI-Rad Companion Organs RTQKB · Traditional	04/10/2026SE
K253057	AI-Rad Companion Brain MRQIH · Traditional	01/22/2026SE
K252838	MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional	12/19/2025SE
K252608	AI-Rad Companion Prostate MRLLZ · Traditional	09/09/2025SE
K250443	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH · Traditional	06/16/2025SE
K242551	syngo Dynamics (Version VA41D)QIH · Traditional	04/03/2025SE
K242745	AI-Rad Companion Organs RTQKB · Traditional	03/27/2025SE
K241770	Prostate MR AI (VA10A)QDQ · Traditional	03/05/2025SE
K240796	myAblation Guide (VB80A)QTZ · Traditional	08/06/2024SE

Questions and answers

When was myAblation Guide (VC10A) cleared by the FDA?

myAblation Guide (VC10A) (K253264) received a 510(k) decision of Substantially Equivalent on June 16, 2026, 260 days after the submission was received.

What is the product code of K253264?

The FDA product code is QTZ – Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 892.2050.