ClearanceBrief
Panels › Radiology › Product code KPS · Class 2

System, Tomography, Computed, Emission

Regulation 892.1200

9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
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Top companies in KPS

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.46137
Philips Medical Systems (Cleveland), Inc.20110
GE Healthcare1275
Ge Medical Systems Israel, Functional Imaging239
GE Medical Systems2713
Adac Laboratories350
Shanghai United Imaging Healthcare Co., Ltd.1814
Philips Medical Systems028
Cti Pet Systems, Inc.184
Trionix Research Laboratory, Inc.161
Decided510(k)Device and applicantCode
Sep 11, 2026K261305MICSI-PET
Microstructure Imaging, Inc.
KPS
Jul 28, 2026K261427uMI Panvivo (uMI Panvivo M)
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
May 21, 2026K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 F
Siemens Medical Solutions USA, Inc.
KPS
Apr 3, 2026K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Feb 13, 2026K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Jan 13, 2026K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERIT
Spectrum Dynamics Medical, Ltd., IL
KPS
Dec 30, 2025K253844AnyScan 3.0 NM Scanner Family
Mediso Medical Imaging Systems, Ltd., HU
KPS
Dec 1, 2025K251370Cartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation, JP
KPS
Nov 25, 2025K251401PennPET Explorer Positron Emission Tomograph
Trustees of the University of Pennsylvania
KPS
Sep 9, 2025K252477Hybrid Viewer (00859873006240)
Hermes Medical Solutions AB, SE
KPS
Aug 15, 2025K250170PHAROS
Brightonix Imaging, KR
KPS
Jul 31, 2025K251561Biograph Trinion
Siemens Medical Solutions USA, Inc.
KPS
Jul 17, 2025K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Jul 3, 2025K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
Siemens Medical Solutions USA, Inc.
KPS
Jun 12, 2025K251153Aurora
Ge Medical Systems Israel, IL
KPS
Mar 3, 2025K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Bracco Diagnostics, Inc.
KPS
Jan 27, 2025K241266Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
Raysolution Healthcare Co., Ltd., CN
KPS
Jan 17, 2025K243605Aurora
Ge Medical Systems Israel, Functional Imaging, IL
KPS
Dec 12, 2024K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Nov 8, 2024K241364Hybrid Viewer (00859873006189)
Hermes Medical Solutions AB, SE
KPS
Oct 30, 2024K243186Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA3
Siemens Medical Solutions USA, Inc.
KPS
Aug 30, 2024K241585uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Aug 15, 2024K241596uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Aug 8, 2024K241665Omni Legend
Ge Medical Systems Israel, Functional Imaging, IL
KPS
Jul 26, 2024K241898Symbia SPECT and SPECT/CT Systems
Siemens Healthineers
KPS
Jul 15, 2024K241751NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
Positrigo AG, CH
KPS
May 24, 2024K240827SET-5002
Shimadzu Corporation Medical Systems Division, JP
KPS
Jan 18, 2024K231762uEXPLORER
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Jan 12, 2024K233677Biograph VK10
Siemens Medical Solutions USA, Inc.
KPS
Oct 3, 2023K232712uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Sep 21, 2023K232569CAREMIBRAIN
General Equipment For Medical Imaging, S.A., ES
KPS
Sep 14, 2023K231576cNeuro cPET
Combinostics OY, FI
KPS
Sep 12, 2023K231748Cartesion Prime (PCD-1000A/3) V10.15
Canon Medical Systems Corporation, JP
KPS
Aug 21, 2023K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
Mcgovern Medical School
KPS
Jul 26, 2023K231572uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Jul 13, 2023K231833Biograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc.
KPS
May 17, 2023K231102Symbia Pro.specta VA20A Family
Siemens Medical Solutions USA, Inc.
KPS
Apr 28, 2023K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERIT
Spectrum Dynamics Medical, Ltd., IL
KPS
Apr 27, 2023K223212Precision DL
GE Healthcare, IL
KPS
Mar 30, 2023K223422Emory Cardiac Toolbox 4.3
Syntermed
KPS
Mar 10, 2023K223325uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd., CN
KPS
Dec 22, 2022K223547Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc.
KPS
Nov 22, 2022K222895DynamicIQ
GE Medical Systems SCS, FR
KPS
Sep 2, 2022K221932Omni Legend
GE Healthcare, IL
KPS
May 31, 2022K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
Ever Fortune.Ai, Co., Ltd., TW
KPS
Feb 4, 2022K214062Radialis PET Camera
Radialis, Inc., CA
KPS
Sep 28, 2021K211964SubtlePET
Subtle Medical, Inc.
KPS
Sep 16, 2021K212604Symbia VA10A Family
Siemens Medical Solutions USA, Inc.
KPS
Aug 27, 2021K212004MyoSPECT, MyoSpect ES
GE Healthcare, IL
KPS
Aug 20, 2021K211846Discovery MI Gen2
Ge Medical Systems, LLC
KPS

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