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FDA 510(k)

syngo.CT Applications

K-Number: K220450 · 2022-03-07

Decision Date2022-03-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Applications 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 2022-03-07 under 510(k) number K220450. 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 Applications?

syngo.CT Applications is a medical device that received FDA 510(k) clearance on 2022-03-07. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K220450.

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

syngo.CT Applications received FDA 510(k) clearance on 2022-03-07, under 510(k) number K220450.

Who is the listed applicant for syngo.CT Applications?

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 Applications?

The FDA product code for syngo.CT Applications is JAK.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.