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FDA 510(k)

syngo.CT Skull Unfolding

K-Number: K203411 · 2021-07-22

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-07-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Skull Unfolding is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K203411. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.CT Skull Unfolding?

syngo.CT Skull Unfolding is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K203411.

When did syngo.CT Skull Unfolding receive FDA 510(k) clearance?

syngo.CT Skull Unfolding received FDA 510(k) clearance on 2021-07-22, under 510(k) number K203411.

Who is the listed applicant for syngo.CT Skull Unfolding?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Skull Unfolding?

The FDA product code for syngo.CT Skull Unfolding is JAK.

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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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