FDA 510(k)

AI-Rad Companion (Pulmonary)

K-Number: K213713 · 2022-08-11

Decision Date2022-08-11

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion (Pulmonary) is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2022-08-11 under approval number K213713. 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 (Pulmonary)?

AI-Rad Companion (Pulmonary) is a medical device that received FDA 510(k) clearance on 2022-08-11. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K213713.

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

AI-Rad Companion (Pulmonary) received FDA 510(k) clearance on 2022-08-11, under approval number K213713.

What company makes AI-Rad Companion (Pulmonary)?

AI-Rad Companion (Pulmonary) is manufactured by Siemens Healthcare GmbH.

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

The FDA product code for AI-Rad Companion (Pulmonary) 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.