KPS — System, Tomography, Computed, Emission Class II
FDA product code KPS covers "System, Tomography, Computed, Emission", a Class II medical device regulated under 21 CFR 892.1200. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPS
- Device Class
- Class II
- Regulation Number
- 892.1200
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261315 | siemens medical solutions usa | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.spect | May 21, 2026 |
| K260524 | shanghai united imaging healthcare co | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panviv | April 3, 2026 |
| K253564 | shanghai united imaging healthcare co | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo | February 13, 2026 |
| K254001 | spectrum dynamics medical | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 | January 13, 2026 |
| K253844 | mediso medical imaging systems | AnyScan 3.0 NM Scanner Family | December 30, 2025 |
| K251370 | canon medical systems corporation | Cartesion Prime (PCD-1000A/3) V10.21 | December 1, 2025 |
| K251401 | trustees of the university of pennsylvania | PennPET Explorer Positron Emission Tomograph | November 25, 2025 |
| K252477 | hermes medical solutions | Hybrid Viewer (00859873006240) | September 9, 2025 |
| K250170 | brightonix imaging | PHAROS | August 15, 2025 |
| K251561 | siemens medical solutions usa | Biograph Trinion | July 31, 2025 |
| K251839 | shanghai united imaging healthcare co | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | July 17, 2025 |
| K251671 | siemens medical solutions usa | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | July 3, 2025 |
| K251153 | ge medical systems israel | Aurora | June 12, 2025 |
| K243881 | bracco diagnostics | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Corona | March 3, 2025 |
| K241266 | raysolution healthcare co | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | January 27, 2025 |
| K243605 | ge medical systems israel, functional imaging | Aurora | January 17, 2025 |
| K243538 | shanghai united imaging healthcare co | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | December 12, 2024 |
| K241364 | hermes medical solutions | Hybrid Viewer (00859873006189) | November 8, 2024 |
| K243186 | siemens medical solutions usa | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.spe | October 30, 2024 |
| K241585 | shanghai united imaging healthcare co | uMI Panorama | August 30, 2024 |