FDA.report

PET/CT system

Definition
A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and CT portions of the system may be used independently or in combination. The PET and CT images may be transferred to other systems for radiation therapy planning or additional processing.
GUDID devices
68
Last updated
2026-01-20 11:33:59

Related Product Codes

CodeDeviceSpecialtyClassDevices
KPSSystem, Tomography, Computed, EmissionRadiology260
JAKSystem, X-Ray, Tomography, ComputedRadiology28

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
04068151048056Biograph Trinion.X EP5 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.117138562026-01-09
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.117138572026-01-09
04068151048087Biograph Trinion.X EP5 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.117138542026-01-09
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.117138582025-08-28
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.uMI 7802025-08-03
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.uMI Panorama 282025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.uMI Panvivo2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.uMI Panvivo S2025-08-03
04056869961064Sparrow HP2 3 RingSIEMENS MEDICAL SOLUTIONS USA, INC.107564742024-01-31
04056869961071Sparrow HP2 4 RingSIEMENS MEDICAL SOLUTIONS USA, INC.107564762024-01-31
04056869961088Sparrow HP4 3 RingSIEMENS MEDICAL SOLUTIONS USA, INC.107564782024-01-31
04056869961095Sparrow HP4 4 RingSIEMENS MEDICAL SOLUTIONS USA, INC.107564792024-01-31
04056869996622Biograph Vision.X EdgeSIEMENS MEDICAL SOLUTIONS USA, INC.117131792023-11-10
04056869996639Biograph Vision.XSIEMENS MEDICAL SOLUTIONS USA, INC.117131762023-11-10
06971576832187uMIShanghai United Imaging Healthcare Co., Ltd.uMI Panorama GS2023-09-21
06971576832170uMIShanghai United Imaging Healthcare Co., Ltd.uMI Panorama 352023-03-20
00884838108103Vereos PET/CT System Upgrade Philips Medical Systems Nederland B.V.8824252022-03-21
04987670103810PET-CT SCANNERCANON MEDICAL SYSTEMS CORPORATIONPCD-1000A2021-12-14
00810030350095uMI VMUIH TECHNOLOGIES LLCuMI 550 VM2021-11-19
00810030350088uMIUIH TECHNOLOGIES LLCuMI 5502021-06-04
06971576832057uMIShanghai United Imaging Healthcare Co., Ltd.uMI 5502020-07-09
04056869238074Biograph Vision 450SIEMENS MEDICAL SOLUTIONS USA, INC.107496692019-07-15
04056869238081Biograph Vision 450 EdgeSIEMENS MEDICAL SOLUTIONS USA, INC.107496712019-07-15
06971576832026uMIShanghai United Imaging Healthcare Co., Ltd.uMI 5502019-04-03
06971576832040uEXPLORERShanghai United Imaging Healthcare Co., Ltd.uEXPLORER2019-03-29
04056869001289Biograph mCT-S (20) -3RSIEMENS MEDICAL SOLUTIONS USA, INC.105077862016-09-24
04056869001296Biograph mCT S(20)-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105341592016-09-24
04056869001302Biograph mCT S(20)-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105341602016-09-24
04056869001319Biograph mCT S(40)-3RSIEMENS MEDICAL SOLUTIONS USA, INC.102486682016-09-24
04056869001326Biograph mCT S(40)-4RSIEMENS MEDICAL SOLUTIONS USA, INC.102486712016-09-24
04056869001333Biograph mCT S(64)-3RSIEMENS MEDICAL SOLUTIONS USA, INC.102486692016-09-24
04056869001340Biograph mCT S(64)-4RSIEMENS MEDICAL SOLUTIONS USA, INC.102486722016-09-24
04056869001357Biograph mCT X-3RSIEMENS MEDICAL SOLUTIONS USA, INC.102486732016-09-24
04056869001364Biograph mCT X-4RSIEMENS MEDICAL SOLUTIONS USA, INC.102486702016-09-24
04056869001371Biograph mCT Flow 20-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105289562016-09-24
04056869001388Biograph mCT Flow 20-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105289582016-09-24
04056869001395Biograph mCT Flow 40-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105291582016-09-24
04056869001401Biograph mCT Flow 40-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105291592016-09-24
04056869001418Biograph mCT Flow 64-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105291602016-09-24
04056869001425Biograph mCT Flow 64-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105291612016-09-24
04056869001432Biograph mCT Flow Edge-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105289542016-09-24
04056869001449Biograph mCT Flow Edge-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105289552016-09-24
04056869001661TOP LEVEL BIOGRAPH 64-3R W/0 CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458542016-09-24
04056869001678TOP LEVEL BIOGRAPH 64-4R W/O CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458562016-09-24
04056869001685TOP LEVEL BIOGRAPH 40-3R W/0 CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458552016-09-24
04056869001692TOP LEVEL BIOGRAPH 40-4R W/0 CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458572016-09-24
04056869001708TOP LEVEL BIOGRAPH 6-3R W/0 CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458582016-09-24
04056869001715TOP LEVEL BIOGRAPH 6-4R W/0 CTSIEMENS MEDICAL SOLUTIONS USA, INC.102458592016-09-24
04056869001722Biograph 16 TruePoint - 3RSIEMENS MEDICAL SOLUTIONS USA, INC.102495552016-09-24
04056869001739Biograph 16 TruePoint TrueV - 4RSIEMENS MEDICAL SOLUTIONS USA, INC.102495562016-09-24
04056869001814Biograph Advanced Workflow (B6)SIEMENS MEDICAL SOLUTIONS USA, INC.100972912016-09-24
04056869001821BIOGRAPH Advanced Workflow (B16)SIEMENS MEDICAL SOLUTIONS USA, INC.102497252016-09-24
04056869001838Biograph Advanced Workflow (B64/40)SIEMENS MEDICAL SOLUTIONS USA, INC.100972842016-09-24
04056869001845Advanced Workflow (MIWP) - mCT non-FlowSIEMENS MEDICAL SOLUTIONS USA, INC.105312882016-09-24
04056869001852Advanced Workflow (MIWP) - mCTSIEMENS MEDICAL SOLUTIONS USA, INC.102492812016-09-24
04056869001869Advanced Workflow (MIWP) - mCT FlowSIEMENS MEDICAL SOLUTIONS USA, INC.105309372016-09-24
04056869001876Advanced Workflow (MIWP) - mCT Flow EdgeSIEMENS MEDICAL SOLUTIONS USA, INC.105317482016-09-24
04056869001883Biograph Remote Workstation VG50ASIEMENS MEDICAL SOLUTIONS USA, INC.105306922016-09-24
04056869001890PET 6.0.1 Remote Recon W/S KitSIEMENS MEDICAL SOLUTIONS USA, INC.102490762016-09-24
04056869011028Biograph Horizon-3RSIEMENS MEDICAL SOLUTIONS USA, INC.105327462016-09-24
04056869011035Biograph Horizon-4RSIEMENS MEDICAL SOLUTIONS USA, INC.105327482016-09-24
04056869183213Biograph Vision 600 Edge (8 Ring/Edge)SIEMENS MEDICAL SOLUTIONS USA, INC.107496722018-08-31
04056869224503Biograph Vision 600 (8 Ring/64 CT)SIEMENS MEDICAL SOLUTIONS USA, INC.107496702018-08-30
04987670100543TOSHIBA SCANNERCANON MEDICAL SYSTEMS CORPORATIONPCA-9000A2018-03-02
06970167440053NeuSight PET/CT Scanner SystemNeusoft Medical Systems Co., Ltd.NeuSight PET/CT 642016-09-19
06970167440060NeuSight PET/CT Scanner SystemNeusoft Medical Systems Co., Ltd.NeuSight PET/CT 162016-09-19
00884838059443Ingenuity TFPhilips Medical Systems (cleveland), Inc.8824422016-09-23
00884838059559Vereos PET/CTPhilips Medical Systems Nederland B.V.8824462017-08-18