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FDA 510(k)

syngo.CT Single Source Dual Energy (Twin Beam)

K-Number: K153220 · 2016-02-19

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-02-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Single Source Dual Energy (Twin Beam) is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K153220. 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 Single Source Dual Energy (Twin Beam)?

syngo.CT Single Source Dual Energy (Twin Beam) is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K153220.

When was syngo.CT Single Source Dual Energy (Twin Beam) approved by the FDA?

syngo.CT Single Source Dual Energy (Twin Beam) received FDA 510(k) clearance on 2016-02-19, under approval number K153220.

What company makes syngo.CT Single Source Dual Energy (Twin Beam)?

syngo.CT Single Source Dual Energy (Twin Beam) is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.CT Single Source Dual Energy (Twin Beam)?

The FDA product code for syngo.CT Single Source Dual Energy (Twin Beam) 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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