FDA-cleared K253023

BIOGRAPH One

Siemens Healthineers AG

BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2026-01-15
FDA-cleared K253532

TruSPECT Processing Station

Spectrum Dynamics Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-12-30
FDA-cleared K251370

Cartesion Prime (PCD-1000A/3) V10.21

Canon Medical Systems Corporation

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-12-01
FDA-cleared K243919

Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Voxel Dosimetry 3.1 calculates voxel-level absorbed-dose maps from post-therapy nuclear-medicine images for FDA-approved therapeutic radiopharmaceuticals and provides reviewed...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-07-30
FDA-cleared K251839

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2025-07-17
FDA-cleared K251153

Aurora

GE Medical Systems Israel

Aurora supports planar nuclear medicine, SPECT/CT, uptake analysis, diagnostic and therapy-monitoring workflows, and reviewed deep-learning kidney segmentation for dynamic renal...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-06-12
FDA-cleared K243538

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co.,Ltd.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-12-12
FDA-cleared K241585

uMI Panorama

Shanghai United Imaging Healthcare Co.,Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT for qualified healthcare professionals across diagnostic, staging, treatment-planning, and response workflows; this...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2024-08-30
FDA-cleared K241596

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-08-15
FDA-cleared K241665

Omni Legend

GE Medical Systems Israel, Functional Imaging

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-08-08
FDA-cleared K234154

uPMR 790

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code OUO identifies this device class as Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance. Imager that generates both both...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-05-24
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2024-01-12
FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-10-03
FDA-cleared K231748

Cartesion Prime (PCD-1000A/3) V10.15

Canon Medical Systems Corporation

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-09-12
FDA-cleared K231572

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-07-26
FDA-cleared K231833

Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-07-13
FDA-cleared K223212

Precision DL

GE Healthcare

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2023-04-27
FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2023-03-10
FDA-cleared K212365

BoneView

Gleamer

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2022-03-01
FDA-cleared K211964

SubtlePET

Subtle Medical, Inc.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-09-28
FDA-cleared K211846

Discovery MI Gen2

GE Medical Systems, LLC.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-08-20
FDA-cleared K212230

TruSPECT Radiological Image Processing Station

Spectrum Dynamics Medical Ltd

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-08-16
FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-08-06
FDA-cleared K210001

HYPER AiR

Shanghai United Imaging Healthcare Co.,Ltd.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-04-30
FDA-cleared K203314

Cartesion Prime (PCD-1000A/3) V10.8

Canon Medical Systems Corporation

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2021-04-23
FDA-cleared K193210

HYPER DLR

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-08-04
FDA-cleared K193248

Biograph Vision, Biograph mCT Family of PET/CTs

Siemens Medical Solutions USA, Inc

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-02-14
FDA-cleared K193178

Biograph Horizon

Siemens Medical Solution USA, Inc.

FDA product code KPS identifies this device class as System, Tomography, Computed, Emission. Consult the linked FDA record for the exact authorized indications for use.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
N/A
Decision
2020-02-12
FDA-cleared K191262

aBSI

EXINI Diagnostics AB

aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2019-08-05