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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 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 2020-07-30 under 510(k) 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. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K193283.

When did AI-Rad Companion Prostate MR receive FDA 510(k) clearance?

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

Who is the listed applicant for AI-Rad Companion Prostate MR?

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 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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