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FDA 510(k)

Syngo Carbon Enterprise Access (VA40A)

K-Number: K240294 · 2024-05-23

ApplicantSiemens Healthcare GmbH
Decision Date2024-05-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Enterprise Access (VA40A) 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 2024-05-23 under 510(k) number K240294. 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 Enterprise Access (VA40A)?

Syngo Carbon Enterprise Access (VA40A) is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K240294.

When did Syngo Carbon Enterprise Access (VA40A) receive FDA 510(k) clearance?

Syngo Carbon Enterprise Access (VA40A) received FDA 510(k) clearance on 2024-05-23, under 510(k) number K240294.

Who is the listed applicant for Syngo Carbon Enterprise Access (VA40A)?

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 Syngo Carbon Enterprise Access (VA40A)?

The FDA product code for Syngo Carbon Enterprise Access (VA40A) is LLZ.

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.

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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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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