System, Tomography, Computed, Emission
FDA product code KPS · 459 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.1200
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-02-28 – 2026-09-11
KPS
2026-09-11
KPS
2026-07-28
uMI Panvivo (uMI Panvivo M)
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KPS
2026-05-21
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family
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KPS
2026-04-03
uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
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KPS
2026-02-13
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
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KPS
2026-01-13
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
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KPS
2025-12-30
AnyScan 3.0 NM Scanner Family
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KPS
2025-12-01
Cartesion Prime (PCD-1000A/3) V10.21
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KPS
2025-11-25
PennPET Explorer Positron Emission Tomograph
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KPS
2025-09-09
Hybrid Viewer (00859873006240)
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KPS
2025-08-15
PHAROS
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KPS
2025-07-31
Biograph Trinion
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KPS
2025-07-17
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
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KPS
2025-07-03
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
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KPS
2025-06-12
Aurora
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KPS
2025-03-03
HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
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KPS
2025-01-27
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
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KPS
2025-01-17
Aurora
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KPS
2024-12-12
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
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KPS
2024-11-08
Hybrid Viewer (00859873006189)
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KPS
2024-10-30
Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
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KPS
2024-08-30
uMI Panorama
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KPS
2024-08-15
uMI Panvivo
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KPS
2024-08-08
Omni Legend
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KPS
2024-07-26
Symbia SPECT and SPECT/CT Systems
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KPS
2024-07-15
NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
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KPS
2024-05-24
SET-5002
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KPS
2024-01-18
uEXPLORER
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KPS
2024-01-12
Biograph VK10
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KPS
2023-10-03
uMI Panorama
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KPS
2023-09-21
CAREMIBRAIN
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KPS
2023-09-14
cNeuro cPET
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KPS
2023-09-12
Cartesion Prime (PCD-1000A/3) V10.15
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KPS
2023-08-21
Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
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KPS
2023-07-26
uMI Panorama
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KPS
2023-07-13
Biograph Vision.X and Biograph Vision.X Edge
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KPS
2023-05-17
Symbia Pro.specta VA20A Family
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KPS
2023-04-28
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
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KPS
2023-04-27
Precision DL
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KPS
2023-03-30
Emory Cardiac Toolbox 4.3
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KPS
2023-03-10
uMI Panorama
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KPS
2022-12-22
Biograph Vision Quadra PET/CT System
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KPS
2022-11-22
DynamicIQ
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KPS
2022-09-02
Omni Legend
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KPS
2022-05-31
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
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KPS
2022-02-04
Radialis PET Camera
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KPS
2021-09-28
SubtlePET
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KPS
2021-09-16
Symbia VA10A Family
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KPS
2021-08-27
MyoSPECT, MyoSpect ES
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KPS
2021-08-20
Discovery MI Gen2
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KPS
2021-08-06
Vereos PET/CT
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KPS
2021-07-27
PET VCAR
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KPS
2021-05-19
Vereos PET/CT
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KPS
2021-05-12
Symbia VA10A Family
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KPS
2021-04-30
HYPER AiR
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KPS
2021-04-23
Cartesion Prime (PCD-1000A/3) V10.8
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KPS
2021-04-12
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
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KPS
2021-04-09
HYPER Focus
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KPS
2021-03-29
StarGuide
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KPS
2021-03-17
BBX-PET Scanner
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KPS
2021-03-03
Biograph Vision Quadra PET/CT System
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KPS
2020-12-23
Affinity
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KPS
2020-10-23
SIR-Spheres Microspheres Activity Calculator (SMAC)
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KPS
2020-10-15
Cartesion Prime, PCD-1000A, V10.7
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KPS
2020-08-27
ANCORIS
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KPS
2020-08-11
ImagenSPECT 3.0
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KPS
2020-08-04
HYPER DLR
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KPS
2020-03-20
Symbia 6.7
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KPS
2020-02-14
Biograph Vision, Biograph mCT Family of PET/CTs
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KPS
2020-02-14
Affinity
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KPS
2020-02-14
CardIQ Flow
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KPS
2020-02-12
Biograph Horizon
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KPS
2020-01-26
Emission Computed Tomography System
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KPS
2019-08-13
Cartesion Prime
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KPS
2019-07-12
VERITON CT whole body SPECT/CT system
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KPS
2019-05-06
Biograph Vision
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KPS
2018-12-18
Emission Computed Tomography System
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KPS
2018-11-30
SubtlePET
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KPS
2018-11-09
VERITON CT whole body SPECT/CT system
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KPS
2018-10-25
Hybrid3D
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KPS
2018-10-12
uMI 550 PET/CT System
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KPS
2018-08-16
NeuroQ 3.8
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KPS
2018-06-12
HeartSee Cardiac P.E.T. Processing Software
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KPS
2018-05-23
Biograph Vision
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KPS
2018-04-25
VERITON NM
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KPS
2018-04-17
NM/CT 850, NM/CT 860
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KPS
2018-04-13
uMI 780 PET/CT System
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KPS
2018-04-11
PET Digital Gating
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KPS
2018-01-12
ImagenUniversal
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KPS
2017-12-20
Biograph mCT Family of PET/CT Systems
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KPS
2017-11-21
Hybrid3D
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KPS
2017-11-21
Hermes Medical Imaging Suite v5.7
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KPS
2017-11-17
Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
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KPS
2017-11-03
CSMC Cardiac Suite
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KPS
2017-10-06
Ingenuity TF
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KPS
2017-09-22
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
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KPS
2017-06-01
Biograph Horizon PET/CT
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KPS
2017-06-01
Celesteion, PCA-9000A/3
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KPS
2017-05-22
Hybrid3D
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KPS
2017-01-09
Symbia Intevo Bold
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