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FDA 510(k)

myAblation Guide (VC10A)

K-Number: K253264 · 2026-06-16

ApplicantSiemens Healthcare GmbH
Decision Date2026-06-16
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

myAblation Guide (VC10A) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253264. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myAblation Guide (VC10A)?

myAblation Guide (VC10A) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K253264.

When did myAblation Guide (VC10A) receive FDA 510(k) clearance?

myAblation Guide (VC10A) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253264.

Who is the listed applicant for myAblation Guide (VC10A)?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myAblation Guide (VC10A)?

The FDA product code for myAblation Guide (VC10A) is QTZ.

Other records listing Siemens Healthcare GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253689syngo Dynamics (VA41F)K252548AI-Rad Companion Organs RTK253057AI-Rad Companion Brain MRK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion Prostate MRK250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

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Related Devices (Code: QTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252947HistoSonics® Planning ToolHistoSonics, Inc.K251931BioTraceIO Vision (V1.7)Techsomed Medical TechnologiesK240796myAblation Guide (VB80A)Siemens Healthcare GmbHK240773VisAble.IOTechsomedK222222Artemis, Artemis TPO, Artemis MXEigenK222938Ablation-fitR.A.W. S.R.L

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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