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FDA 510(k)

syngo.CT Dual Energy

K-Number: K191468 · 2019-07-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-07-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Dual Energy 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 2019-07-03 under 510(k) number K191468. 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 Dual Energy?

syngo.CT Dual Energy is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K191468.

When did syngo.CT Dual Energy receive FDA 510(k) clearance?

syngo.CT Dual Energy received FDA 510(k) clearance on 2019-07-03, under 510(k) number K191468.

Who is the listed applicant for syngo.CT Dual Energy?

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 Dual Energy?

The FDA product code for syngo.CT Dual Energy 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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