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FDA 510(k)

AI-Rad Companion Engine

K-Number: K193294 · 2020-07-10

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-07-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Engine 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 2020-07-10 under 510(k) number K193294. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion Engine?

AI-Rad Companion Engine is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K193294.

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

AI-Rad Companion Engine received FDA 510(k) clearance on 2020-07-10, under 510(k) number K193294.

Who is the listed applicant for AI-Rad Companion Engine?

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 Engine?

The FDA product code for AI-Rad Companion Engine is LLZ.

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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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