2 devices · 2 companies · 2022 to 2026
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: AI-enabled devices on FDA's list
2 devices from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2022 to 2026, 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 (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Automated Aortic Stenosis SoftwareK254161 · 510(k) | Radiology | POK | database entry | |
| Vivid iqK221148 · 510(k) | Radiology | IYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.