26 devices · 13 companies · 2018 to 2026
Product code KPS: System, Tomography, Computed, Emission
26 devices under product code KPS, 2018 to 2026, from 13 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (26 of 26 here), the regulation, and MAUDE report counts by product code.
System, Tomography, Computed, Emission. 21 CFR 892.1200, Class II. MAUDE held 1,054 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| uMI PanvivoK260524 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| uMI PanvivoK253564 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| VERITON CT 300 Series Digital SPECT/CT SystemK254001 · 510(k) | Spectrum Dynamics Medical, Ltd. | Radiology | database entry | |
| Cartesion PrimeK251370 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| uMI PanvivoK251839 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| AuroraK251153 · 510(k) | GE Medical Systems Israel | Radiology | database entry | |
| uMI PanvivoK243538 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | database entry | |
| uMI PanoramaK241585 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | database entry | |
| uMI PanvivoK241596 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Omni LegendK241665 · 510(k) | GE Medical Systems Israel, Functional Imaging | Radiology | database entry | |
| Biograph VK10K233677 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| uMI PanoramaK232712 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Cartesion PrimeK231748 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| uMI PanoramaK231572 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Biograph Vision.X and Biograph Vision.X EdgeK231833 · 510(k) | Siemens Medical Solutions USA, Inc. | Radiology | database entry | |
| Precision DLK223212 · 510(k) | GE Healthcare | Radiology | database entry | |
| uMI PanoramaK223325 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| SubtlePETK211964 · 510(k) | Subtle Medical, Inc. | Radiology | database entry | |
| Discovery MI Gen2K211846 · 510(k) | GE Medical Systems, LLC. | Radiology | database entry | |
| Vereos PET/CTK211764 · 510(k) | Philips Medical Systems Nederland B.V. | Radiology | database entry | |
| HYPER AiRK210001 · 510(k) | Shanghai United Imaging Healthcare Co.,Ltd. | Radiology | database entry | |
| Cartesion PrimeK203314 · 510(k) | Canon Medical Systems Corporation | Radiology | database entry | |
| HYPER DLRK193210 · 510(k) | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | database entry | |
| Biograph Vision, Biograph mCT Family of PET/CTsK193248 · 510(k) | Siemens Medical Solutions USA, Inc | Radiology | database entry | |
| Biograph HorizonK193178 · 510(k) | Siemens Medical Solution USA, Inc. | Radiology | database entry | |
| SubtlePETK182336 · 510(k) | Subtle Medical, Inc. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.