3 devices · 2 companies · 2021 to 2024
Samsung Electronics Co., Ltd: AI-enabled devices on FDA's list
3 devices from Samsung Electronics Co., Ltd, 2021 to 2024, from 2 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Samsung Electronics Co., Ltd
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Sleep Apnea FeatureDEN230041 · De Novo | Anesthesiology | QZW | database entry | |
| Samsung ECG Monitor Application with Irregular HK230292 · 510(k) | Cardiovascular | QDA | database entry | |
| Auto Lung Nodule DetectionK201560 · 510(k) | Radiology | MYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.