Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ProFound Detection (V4.0)

K-Number: K240417 · 2024-11-08

ApplicantIcad, Inc.
Decision Date2024-11-08
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProFound Detection (V4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K240417. 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 Detection (V4.0)?

ProFound Detection (V4.0) is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Icad, Inc.. The 510(k) number is K240417.

When did ProFound Detection (V4.0) receive FDA 510(k) clearance?

ProFound Detection (V4.0) received FDA 510(k) clearance on 2024-11-08, under 510(k) number K240417.

Who is the listed applicant for ProFound Detection (V4.0)?

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 Detection (V4.0)?

The FDA product code for ProFound Detection (V4.0) 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.

K211506PowerLook Density Assessment V4.0K203822ProFound AI Software V3.0K191994ProFound AI Software V2.1K182373PowerLook Tomo Detection V2 SoftwareK180125PowerLook Density Assessment SoftwarePMA P160009Analyzer, medical image

View all 9 devices →

Related Devices (Code: QDQ)

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.

K260898Transpara (2.1.0)Screenpoint Medical B.V.K260086CadAI-B DxBeamWorks, Inc.K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.K260714MammoScreen® (5)TherapixelK253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib 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.

↑