5 devices · 2 companies · 2021 to 2026
Philips Healthcare (Suzhou) Co., Ltd.: AI-enabled devices on FDA's list
5 devices from Philips Healthcare (Suzhou) Co., Ltd., 2021 to 2026, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| CT Rembra RTK252992 · 510(k) | Radiology | JAK | database entry | |
| CT 5300K232491 · 510(k) | Radiology | JAK | database entry | |
| Philips CT 3500K223311 · 510(k) | Radiology | JAK | database entry | |
| Philips Incisive CTK212441 · 510(k) | Radiology | JAK | database entry | |
| Precise PositionK203514 · 510(k) | Radiology | JAK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.