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FDA 510(k)

syngo. CT Extended Functionalities

K-Number: K203699 · 2021-04-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-04-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo. CT Extended Functionalities is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-04-30 under approval number K203699. 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 Extended Functionalities?

syngo. CT Extended Functionalities is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K203699.

When was syngo. CT Extended Functionalities approved by the FDA?

syngo. CT Extended Functionalities received FDA 510(k) clearance on 2021-04-30, under approval number K203699.

What company makes syngo. CT Extended Functionalities?

syngo. CT Extended Functionalities is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo. CT Extended Functionalities?

The FDA product code for syngo. CT Extended Functionalities 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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