# K191994: ProFound AI Software V2.1

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Oct 4, 2019 after 70 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180005 (2018). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182373: PowerLook Tomo Detection V2 Software, Icad, Inc. (2018) Summary page 4.

## Most influential descendants
- K203822: ProFound AI Software V3.0 (2021), 1 descendant of its own
- K240417: ProFound Detection (V4.0) (2024), 0 descendants of its own

## Indications for use
ProFound™ AI V2.1 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician .

Source page: https://510kreport.com/device/K191994
Methodology: https://510kreport.com/methodology