KPS · System, Tomography, Computed, Emission
Radiology · 21 CFR 892.1200 · Class 2
Overview
| Product Code | KPS |
|---|---|
| Device Name | System, Tomography, Computed, Emission |
| Regulation | 21 CFR 892.1200 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 470)
Showing 20 most recent of 470 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Apr 3, 2026 | SESE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | Feb 13, 2026 | SESE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | Jan 13, 2026 | SESE |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | Dec 30, 2025 | SESE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | Dec 1, 2025 | SESE |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | Nov 25, 2025 | SESE |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | Sep 9, 2025 | SESE |
| K250170 | PHAROS | Brightonix Imaging | Aug 15, 2025 | SESE |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | Jul 31, 2025 | SESE |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | Jul 17, 2025 | SESE |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | Jul 3, 2025 | SESE |
| K251153 | Aurora | Ge Medical Systems Israel | Jun 12, 2025 | SESE |
| K243881 | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. | Mar 3, 2025 | SESE |
| K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | Jan 27, 2025 | SESE |
| K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | Jan 17, 2025 | SESE |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | Dec 12, 2024 | SESE |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | Nov 8, 2024 | SESE |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | Siemens Medical Solutions USA, Inc. | Oct 30, 2024 | SESE |
| K241585 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Aug 30, 2024 | SESE |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | Aug 15, 2024 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 45 clearances
- Adac Laboratories — 35 clearances
- Philips Medical Systems (Cleveland), Inc. — 20 clearances
- Cti Pet Systems, Inc. — 18 clearances
- GE Medical Systems — 17 clearances
