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FDA 510(k)

ProFound AI Software V2.1

K-Number: K191994 · 2019-10-04

ApplicantIcad, Inc.
Decision Date2019-10-04
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProFound AI Software V2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K191994. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProFound AI Software V2.1?

ProFound AI Software V2.1 is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Icad, Inc.. The 510(k) number is K191994.

When did ProFound AI Software V2.1 receive FDA 510(k) clearance?

ProFound AI Software V2.1 received FDA 510(k) clearance on 2019-10-04, under 510(k) number K191994.

Who is the listed applicant for ProFound AI Software V2.1?

The FDA 510(k) record lists Icad, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProFound AI Software V2.1?

The FDA product code for ProFound AI Software V2.1 is QDQ.

Other records listing Icad, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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