# K243684: BrightHeart View Classifier

- Pathway: 510(k) (Traditional)
- Applicant: Brightheart
- Decided: May 7, 2025 after 159 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K935595 (1995). 148 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230209: Sonix Health, Ontact Health Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K251456: BrightHeart View Classifier (2025), 0 descendants of its own

## Indications for use
The BrightHeart View Classifier device is intended to analyze fetal 2D ultrasound images and video clips using machine learning techniques to automatically detect standard views during fetal heart scanning. The BrightHeart View Classifier device is intended to be used as an adjunct to the acquisition and interpretation of fetal anatomic ultrasound examinations at the second or third trimester of pregnancy performed with transabdominal probes.

Source page: https://510kreport.com/device/K243684
Methodology: https://510kreport.com/methodology