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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 a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2019-10-04 under approval 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. It is manufactured by Icad, Inc.. The 510(k) number is K191994.

When was ProFound AI Software V2.1 approved by the FDA?

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

What company makes ProFound AI Software V2.1?

ProFound AI Software V2.1 is manufactured by Icad, Inc..

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

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

Related Clinical Trials

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Related Devices (Code: QDQ)

K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. K181704TransparaScreenpoint Medical B.V. K192287TransparaScreenpoint Medical B.V. K201019Genius AI DetectionHologic, Inc. K192854MammoScreenTherapixel K193229TransparaScreenpoint Medical B.V.

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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