- Advisory panel
- Radiology
- Total cleared
- 470
Recent clearances under product code KPS
1–100 of 470 - 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. ·
- 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. ·
- 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. ·
- K253844 — AnyScan 3.0 NM Scanner Family Mediso Medical Imaging Systems, Ltd. ·
- K251370 — Cartesion Prime (PCD-1000A/3) V10.21 Canon Medical Systems Corporation ·
- K251401 — PennPET Explorer Positron Emission Tomograph Trustees of the University of Pennsylvania ·
- K252477 — Hybrid Viewer (00859873006240) Hermes Medical Solutions AB ·
- K250170 — PHAROS Brightonix Imaging ·
- K251561 — Biograph Trinion Siemens Medical Solutions USA, Inc. ·
- K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) Shanghai United Imaging Healthcare Co., Ltd. ·
- K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems Siemens Medical Solutions USA, Inc. ·
- K251153 — Aurora Ge Medical Systems Israel ·
- K243881 — HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 Bracco Diagnostics, Inc. ·
- K241266 — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) Raysolution Healthcare Co., Ltd. ·
- K243605 — Aurora Ge Medical Systems Israel, Functional Imaging ·
- K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) Shanghai United Imaging Healthcare Co., Ltd. ·
- K241364 — Hybrid Viewer (00859873006189) Hermes Medical Solutions AB ·
- 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. ·
- K241585 — uMI Panorama Shanghai United Imaging Healthcare Co., Ltd. ·
- K241596 — uMI Panvivo Shanghai United Imaging Healthcare Co., Ltd. ·
- K241665 — Omni Legend Ge Medical Systems Israel, Functional Imaging ·
- K241898 — Symbia SPECT and SPECT/CT Systems Siemens Healthineers ·
- K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat Positrigo AG ·
- K240827 — SET-5002 Shimadzu Corporation Medical Systems Division ·
- K231762 — uEXPLORER Shanghai United Imaging Healthcare Co., Ltd. ·
- K233677 — Biograph VK10 Siemens Medical Solutions USA, Inc. ·
- K232712 — uMI Panorama Shanghai United Imaging Healthcare Co., Ltd. ·
- K232569 — CAREMIBRAIN General Equipment For Medical Imaging, S.A. ·
- K231576 — cNeuro cPET Combinostics OY ·
- K231748 — Cartesion Prime (PCD-1000A/3) V10.15 Canon Medical Systems Corporation ·
- K231731 — Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 Mcgovern Medical School ·
- K231572 — uMI Panorama Shanghai United Imaging Healthcare Co., Ltd. ·
- K231833 — Biograph Vision.X and Biograph Vision.X Edge Siemens Medical Solutions USA, Inc. ·
- K231102 — Symbia Pro.specta VA20A Family Siemens Medical Solutions USA, Inc. ·
- K230600 — 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. ·
- K223212 — Precision DL GE Healthcare ·
- K223422 — Emory Cardiac Toolbox 4.3 Syntermed ·
- K223325 — uMI Panorama Shanghai United Imaging Healthcare Co., Ltd. ·
- K223547 — Biograph Vision Quadra PET/CT System Siemens Medical Solutions USA, Inc. ·
- K222895 — DynamicIQ GE Medical Systems SCS ·
- K221932 — Omni Legend GE Healthcare ·
- K213731 — EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows Ever Fortune.Ai, Co., Ltd. ·
- K214062 — Radialis PET Camera Radialis, Inc. ·
- K211964 — SubtlePET Subtle Medical, Inc. ·
- K212604 — Symbia VA10A Family Siemens Medical Solutions USA, Inc. ·
- K212004 — MyoSPECT, MyoSpect ES GE Healthcare ·
- K211846 — Discovery MI Gen2 Ge Medical Systems, LLC ·
- K211764 — Vereos PET/CT Philips Medical Systems Nederland B.V. ·
- K211247 — PET VCAR GE Medical Systems SCS ·
- K210880 — Vereos PET/CT Philips Medical Systems Nederland B.V. ·
- K210557 — Symbia VA10A Family Siemens Medical Solutions USA, Inc. ·
- K210001 — HYPER AiR Shanghai United Imaging Healthcare Co., Ltd. ·
- K203314 — Cartesion Prime (PCD-1000A/3) V10.8 Canon Medical Systems Corporation ·
- K202679 — Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 Mcgovern Medical School ·
- K210418 — HYPER Focus Shanghai United Imaging Healthcare Co., Ltd. ·
- K210173 — StarGuide GE Healthcare ·
- K210450 — BBX-PET Scanner Prescient Imaging, LLC ·
- K210262 — Biograph Vision Quadra PET/CT System Siemens Medical Solutions USA, Inc. ·
- K202882 — Affinity Hermes Medical Solutions AB ·
- K202392 — SIR-Spheres Microspheres Activity Calculator (SMAC) Sirtex Medical US Holdings, Inc. ·
- K202349 — Cartesion Prime, PCD-1000A, V10.7 Canon Medical Systems Corporation ·
- K201807 — ANCORIS Miegmbh ·
- K201933 — ImagenSPECT 3.0 Cardiovascular Imaging Technologies ·
- K193210 — HYPER DLR Shanghai United Imaging Healthcare Co., Ltd. ·
- K200474 — Symbia 6.7 Siemens Medical Solutions USA, Inc. ·
- K192277 — CardIQ Flow GE Medical Systems SCS ·
- K193152 — Affinity Hermes Medical Solutions AB ·
- K193248 — Biograph Vision, Biograph mCT Family of PET/CTs Siemens Medical Solutions USA, Inc. ·
- K193178 — Biograph Horizon Siemens Medical Solution USA, Inc. ·
- K193241 — Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd. ·
- K191582 — Cartesion Prime Canon Medical Systems Corporation ·
- K190457 — VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical, Ltd. ·
- K190900 — Biograph Vision Siemens Medical Solutions USA, Inc. ·
- K182938 — Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd. ·
- K182336 — SubtlePET Subtle Medical, Inc. ·
- K182484 — VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical, Ltd. ·
- K181468 — Hybrid3D Hermes Medical Solutions AB ·
- K182237 — uMI 550 PET/CT System Shanghai United Imaging Healthcare Co., Ltd. ·
- K180077 — NeuroQ 3.8 Syntermed ·
- K181343 — HeartSee Cardiac P.E.T. Processing Software Bracco Diagnostics, Inc. ·
- K180811 — Biograph Vision Siemens Medical Solutions USA, Inc. ·
- K180514 — VERITON NM Spectrum Dynamics Medical, Ltd. ·
- K173816 — NM/CT 850, NM/CT 860 GE Healthcare ·
- K172143 — uMI 780 PET/CT System Shanghai United Imaging Healthcare Co., Ltd. ·
- K180318 — PET Digital Gating Ge Medical Systems, LLC ·
- K173547 — ImagenUniversal Cardiovascular Imaging Technologies ·
- K173578 — Biograph mCT Family of PET/CT Systems Siemens Medical Solutions USA, Inc. ·
- K171681 — Hermes Medical Imaging Suite v5.7 Hermes Medical Solutions AB ·
- K171719 — Hybrid3D Hermes Medical Solutions AB ·
- K173023 — Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold Siemens Medical Solutions USA, Inc. ·
- K172609 — CSMC Cardiac Suite Cedars-Sinai Medical Center ·
- K172406 — Ingenuity TF Philips Medical Systems (Cleveland), Inc. ·
- K171303 — Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 University of Texas Medical School AT Houston, Texas ·
- K170490 — Celesteion, PCA-9000A/3 Toshibamedical Systems Corporation ·
- K170904 — Biograph Horizon PET/CT Siemens Medical Solutions USA, Inc. ·
- K163394 — Hybrid3D Hermes Medical Solutions AB ·
- K162483 — Symbia Intevo Bold Siemens Medical Solutions USA, Inc. ·
- K161740 — D-SPECT Scanner, D-SPECT L Scanner Spectrum Dynamics Medical, Ltd. ·
- K162736 — Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT Siemens Medical Solutions USA, Inc. ·
- K161674 — QuantumCam Ddd-Diagnostic A/S ·
Data sourced from openFDA.
This site is unofficial and independent of the FDA.