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FDA 510(k)

Syngo Carbon Space VA20A

K-Number: K213665 · 2022-06-21

ApplicantSiemens Healthcare GmbH
Decision Date2022-06-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Syngo Carbon Space VA20A 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 2022-06-21 under 510(k) number K213665. 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 VA20A?

Syngo Carbon Space VA20A is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K213665.

When did Syngo Carbon Space VA20A receive FDA 510(k) clearance?

Syngo Carbon Space VA20A received FDA 510(k) clearance on 2022-06-21, under 510(k) number K213665.

Who is the listed applicant for Syngo Carbon Space VA20A?

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 Space VA20A?

The FDA product code for Syngo Carbon Space VA20A 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.

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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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