5 devices · 2 companies · 2024 to 2025
Brightheart: AI-enabled devices on FDA's list
5 devices from Brightheart, 2024 to 2025, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Brightheart
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Fetal EchoScanK252294 · 510(k) | Radiology | POK | database entry | |
| BrightHeart View ClassifierK251456 · 510(k) | Radiology | QIH | database entry | |
| BrightHeart View ClassifierK243684 · 510(k) | Radiology | QIH | database entry | |
| Fetal EchoScanK251071 · 510(k) | Radiology | POK | database entry | |
| Fetal EchoScanK242342 · 510(k) | Radiology | POK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.