3 devices · 1 company · 2025 to 2026
Siemens Healthineers AG: AI-enabled devices on FDA's list
3 devices from Siemens Healthineers AG, 2025 to 2026, from 1 company across 2 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 Siemens Healthineers AG
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| LungMapsK253690 · 510(k) | Radiology | QIH | database entry | |
| BIOGRAPH OneK253023 · 510(k) | Radiology | OUO | database entry | |
| Syngo Carbon ClinicalsK251059 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.