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FDA 510(k)

AI-Rad Companion Prostate MR

K-Number: K193283 · 2020-07-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-07-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Prostate MR is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-07-30 under approval number K193283. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion Prostate MR?

AI-Rad Companion Prostate MR is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193283.

When was AI-Rad Companion Prostate MR approved by the FDA?

AI-Rad Companion Prostate MR received FDA 510(k) clearance on 2020-07-30, under approval number K193283.

What company makes AI-Rad Companion Prostate MR?

AI-Rad Companion Prostate MR is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for AI-Rad Companion Prostate MR?

The FDA product code for AI-Rad Companion Prostate MR is QIH.

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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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