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FDA 510(k)

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis

K-Number: K173637 · 2018-03-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-03-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis 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 2018-03-30 under 510(k) number K173637. 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 Coronary Analysis; syngo.CT Vascular Analysis?

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K173637.

When did syngo.CT Coronary Analysis; syngo.CT Vascular Analysis receive FDA 510(k) clearance?

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis received FDA 510(k) clearance on 2018-03-30, under 510(k) number K173637.

Who is the listed applicant for syngo.CT Coronary Analysis; syngo.CT Vascular Analysis?

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 Coronary Analysis; syngo.CT Vascular Analysis?

The FDA product code for syngo.CT Coronary Analysis; syngo.CT Vascular Analysis 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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