FDA 510(k)

syngo.CT Cardiac Planning

K-Number: K170221 · 2017-04-21

Decision Date2017-04-21

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

syngo.CT Cardiac Planning is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2017-04-21 under approval number K170221. 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 Cardiac Planning?

syngo.CT Cardiac Planning is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K170221.

When was syngo.CT Cardiac Planning approved by the FDA?

syngo.CT Cardiac Planning received FDA 510(k) clearance on 2017-04-21, under approval number K170221.

What company makes syngo.CT Cardiac Planning?

syngo.CT Cardiac Planning is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for syngo.CT Cardiac Planning?

The FDA product code for syngo.CT Cardiac Planning 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.