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FDA 510(k)

ProFound AI Software V3.0

K-Number: K203822 · 2021-03-12

ApplicantIcad, Inc.
Decision Date2021-03-12
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProFound AI Software V3.0 is a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2021-03-12 under approval number K203822. 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 V3.0?

ProFound AI Software V3.0 is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by Icad, Inc.. The 510(k) number is K203822.

When was ProFound AI Software V3.0 approved by the FDA?

ProFound AI Software V3.0 received FDA 510(k) clearance on 2021-03-12, under approval number K203822.

What company makes ProFound AI Software V3.0?

ProFound AI Software V3.0 is manufactured by Icad, Inc..

What is the FDA product code for ProFound AI Software V3.0?

The FDA product code for ProFound AI Software V3.0 is QDQ.

Related Clinical Trials

NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING

Other Devices by Icad, Inc.

K153570Axxent Electronic Brachytherapy System Model 110 XP 1200 K182373PowerLook Tomo Detection V2 Software K180125PowerLook Density Assessment Software K191994ProFound AI Software V2.1 K211506PowerLook Density Assessment V4.0 K240417ProFound Detection (V4.0)

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Related Devices (Code: QDQ)

K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. K181704TransparaScreenpoint Medical B.V. K192287TransparaScreenpoint Medical B.V. K191994ProFound AI Software V2.1Icad, Inc. K201019Genius AI DetectionHologic, Inc. K192854MammoScreenTherapixel

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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