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FDA 510(k)

syngo.CT CaScoring

K-Number: K221219 · 2022-05-17

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2022-05-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT CaScoring 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 2022-05-17 under 510(k) number K221219. 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 CaScoring?

syngo.CT CaScoring is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K221219.

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

syngo.CT CaScoring received FDA 510(k) clearance on 2022-05-17, under 510(k) number K221219.

Who is the listed applicant for syngo.CT CaScoring?

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 CaScoring?

The FDA product code for syngo.CT CaScoring 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.

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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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