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FDA 510(k)

syngo.CT Extended Functionality

K-Number: K163341 · 2017-02-09

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-02-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Extended Functionality is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval number K163341. 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 Functionality?

syngo.CT Extended Functionality is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163341.

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

syngo.CT Extended Functionality received FDA 510(k) clearance on 2017-02-09, under approval number K163341.

What company makes syngo.CT Extended Functionality?

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

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

The FDA product code for syngo.CT Extended Functionality 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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