# Brightheart

- Location (FDA's records): Paris, FR
- FDA decisions: 5 (2024–2025): 5 510(k) clearances
- Product codes: POK (3), QIH (2)
- 510(k) review time since 2016: median 99 days, against 150 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ontact Health Co., Ltd.: 1 (https://510kreport.com/company/ontact-health)
- Ultromics Limited: 1 (https://510kreport.com/company/ultromics)

## Its most-cited devices
- K242342: Fetal EchoScan (2024), cited by 2
- K243684: BrightHeart View Classifier (2025), cited by 1
- K251071: Fetal EchoScan (v1.1) (2025), cited by 1

## Recent decisions
- K252294: Fetal EchoScan (v1.2) (Dec 8, 2025)
- K251456: BrightHeart View Classifier (Jun 5, 2025)
- K243684: BrightHeart View Classifier (May 7, 2025)
- K251071: Fetal EchoScan (v1.1) (May 2, 2025)
- K242342: Fetal EchoScan (Nov 14, 2024)

Source page: https://510kreport.com/company/brightheart