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FDA 510(k)

syngo.MR Applications (VB80)

K-Number: K253495 · 2025-11-20

ApplicantSiemens Healthineers AG
Decision Date2025-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.MR Applications (VB80) is a medical device manufactured by Siemens Healthineers AG. It received FDA 510(k) clearance on 2025-11-20 under approval number K253495. 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.MR Applications (VB80)?

syngo.MR Applications (VB80) is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Siemens Healthineers AG. The 510(k) number is K253495.

When was syngo.MR Applications (VB80) approved by the FDA?

syngo.MR Applications (VB80) received FDA 510(k) clearance on 2025-11-20, under approval number K253495.

What company makes syngo.MR Applications (VB80)?

syngo.MR Applications (VB80) is manufactured by Siemens Healthineers AG.

What is the FDA product code for syngo.MR Applications (VB80)?

The FDA product code for syngo.MR Applications (VB80) is LLZ.

Other Devices by Siemens Healthineers AG

K251059Syngo Carbon Clinicals (VA41) K253023BIOGRAPH One

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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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