9 devices · 2 companies · 2021 to 2026
Philips Medical Systems Nederland B.V.: AI-enabled devices on FDA's list
9 devices from Philips Medical Systems Nederland B.V., 2021 to 2026, from 2 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Philips Medical Systems Nederland B.V.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| EchoNavigator R5.0K253614 · 510(k) | Radiology | QIH | database entry | |
| AV Cardiac CTK260169 · 510(k) | Radiology | JAK | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition S/X, IngeniK253648 · 510(k) | Radiology | LNH | database entry | |
| AV VascularK253735 · 510(k) | Radiology | QIH | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia AmK251397 · 510(k) | Radiology | LNH | database entry | |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia AmK223458 · 510(k) | Radiology | LNH | database entry | |
| Achieva, Ingenia, Ingenia CX, Ingenia Elition anK213583 · 510(k) | Radiology | LNH | database entry | |
| Precise ImageK210760 · 510(k) | Radiology | JAK | database entry | |
| Vereos PET/CTK211764 · 510(k) | Radiology | KPS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.