Modality
42 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Subtle Medical, Inc.
SubtleHD-PET 1.x is image-processing software that reduces PET or PET/CT/PET-MR image noise for images acquired with any radiotracer within the labeled workflow.
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo variants acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, attenuation correction, and the labeled...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo PET/CT acquires anatomical CT and functional PET images of radiopharmaceutical distribution for qualified diagnostic and treatment-planning workflows, including...
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...
Spectrum Dynamics Medical, Ltd.
VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring....
Spectrum Dynamics Medical, Ltd.
TruSPECT Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals; TruClear AI SPECT enhancement supports the...
Canon Medical Systems Corporation
Cartesion Prime PET/CT acquires cross-sectional CT images and PET radiopharmaceutical-distribution images and includes AiCE-i PET processing and a neural-network...
Hermes Medical Solutions AB
Voxel Dosimetry 3.1 calculates voxel-level absorbed-dose maps from nuclear-medicine images acquired after administration of FDA-approved therapeutic radiopharmaceuticals and...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo and Panvivo S acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, and the labeled oncology, cardiology,...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for...
GE Medical Systems Israel
Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance,...
GE Medical Systems Israel, Functional Imaging
Clarify DL is a deep-learning reconstruction function intended to reduce noise and improve image quality of nuclear-medicine bone SPECT scintigraphy for all ages on the supported...
Shanghai United Imaging Healthcare Co.,Ltd.
The uMI Panvivo PET/CT system provides anatomical and functional images. PET depicts the distribution of approved radiopharmaceuticals and CT provides diagnostic tomographic and...
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...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide trained healthcare professionals with viewing, manipulation, quantification, analysis, and comparison of PET or...
Shanghai United Imaging Healthcare Co., Ltd.
The uMI Panvivo is a PET/CT system for anatomical and functional images. PET provides distribution information for approved radiopharmaceuticals and CT provides diagnostic...
GE Medical Systems Israel, Functional Imaging
Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...
Shanghai United Imaging Healthcare Co., Ltd.
The uPMR 790 combines MR and PET devices to provide registered and fused high-resolution physiologic and anatomic information acquired simultaneously and isocentrically. The FDA...
Siemens Medical Solutions USA, Inc.
The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows VB80A, Scenium VE60, and syngo MBF VB30 support PET, SPECT, nuclear-medicine, CT, and MR viewing, quantification, analysis, longitudinal comparison, organ...
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...
Canon Medical Systems Corporation
Cartesion Prime is a PET/CT system for acquisition, reconstruction, fusion, visualization, and professional interpretation within the cleared configuration and radiopharmaceutical...
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...
Siemens Medical Solutions USA, Inc.
The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...
GE Healthcare
Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.
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...
GE Healthcare
The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...
EXINI Diagnostics AB
aPROMISE X accepts, stores, displays, manipulates, quantifies, and reports digital medical images from nuclear-medicine imaging using PSMA PET/CT, with tools for marking regions...
Subtle Medical, Inc.
SubtlePET is DICOM image-processing software that reduces noise in labeled FDG, amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA PET images for radiologist or...
GE Medical Systems, LLC.
Discovery MI Gen2 acquires and displays PET/CT images of radiopharmaceutical distribution and anatomical structures for qualified nuclear-medicine and radiology professionals...
Spectrum Dynamics Medical Ltd
TruSPECT Radiological Image Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals in the labeled SPECT...
Philips Medical Systems Nederland B.V.
Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...
EXINI Diagnostics AB
aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations...
Shanghai United Imaging Healthcare Co.,Ltd.
HYPER AiR provides the cleared nuclear-medicine image-processing support described in K210001 for supported PET/CT studies; outputs require review by qualified professionals and...
Canon Medical Systems Corporation
Cartesion Prime is a PET/CT system for acquisition, reconstruction, fusion, visualization, and professional interpretation within the cleared configuration and radiopharmaceutical...
Siemens Medical Solutions USA, Inc.
syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points,...
GE Healthcare
Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from...
Shanghai United Imaging Healthcare Co., Ltd.
HYPER DLR is an image-processing function intended for radiologists and nuclear-medicine physicians to reduce noise in fluorodeoxyglucose PET images. The software is intended to...
Siemens Medical Solutions USA, Inc
Biograph Vision and Biograph mCT are combined PET/CT systems for acquiring, reconstructing, fusing, displaying, evaluating, and archiving PET and CT studies across labeled...
Siemens Medical Solution USA, Inc.
Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.
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...
Subtle Medical, Inc.
SubtlePET V1.0.0 is image-processing software for transfer, storage, and noise reduction of FDG and amyloid PET images, including PET/CT and PET/MR studies.