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FDA 510(k)

AI-Rad Companion (Cardiovascular)

K-Number: K183268 · 2019-09-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-09-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion (Cardiovascular) is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-09-10 under approval number K183268. 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 AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is a medical device that received FDA 510(k) clearance on 2019-09-10. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K183268.

When was AI-Rad Companion (Cardiovascular) approved by the FDA?

AI-Rad Companion (Cardiovascular) received FDA 510(k) clearance on 2019-09-10, under approval number K183268.

What company makes AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for AI-Rad Companion (Cardiovascular)?

The FDA product code for AI-Rad Companion (Cardiovascular) 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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