3 devices · 2 companies · 2021 to 2026
Spectrum Dynamics Medical, Ltd.: AI-enabled devices on FDA's list
3 devices from Spectrum Dynamics Medical, Ltd., 2021 to 2026, 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 Spectrum Dynamics Medical, Ltd.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| VERITON CT 300 Series Digital SPECT/CT SystemK254001 · 510(k) | Radiology | KPS | database entry | |
| TruSPECT Processing StationK253532 · 510(k) | Radiology | QIH | database entry | |
| TruSPECT Radiological Image Processing StationK212230 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.