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FDA 510(k)

Syngo Carbon Space (VA4)

K-Number: K263048 · 2026-09-29

ApplicantSiemens Healthineers AG
Decision Date2026-09-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Space (VA4) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers AG. It received FDA 510(k) clearance on 2026-09-29 under 510(k) number K263048. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syngo Carbon Space (VA4)?

Syngo Carbon Space (VA4) is a medical device that received FDA 510(k) clearance on 2026-09-29. The listed applicant is Siemens Healthineers AG. The 510(k) number is K263048.

When did Syngo Carbon Space (VA4) receive FDA 510(k) clearance?

Syngo Carbon Space (VA4) received FDA 510(k) clearance on 2026-09-29, under 510(k) number K263048.

Who is the listed applicant for Syngo Carbon Space (VA4)?

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

What is the FDA product code for Syngo Carbon Space (VA4)?

The FDA product code for Syngo Carbon Space (VA4) is LLZ.

Related Clinical Trials

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.

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Other records listing Siemens Healthineers AG 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.

K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureK253690LungMapsK253023BIOGRAPH OneK253495syngo.MR Applications (VB80)K251059Syngo Carbon Clinicals (VA41)

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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