Shanghai United Imaging Healthcare Co., Ltd. radiology AI products

FDA-cleared K260113

uMR Astra

Shanghai United Imaging Healthcare Co., Ltd.

uMR Astra is a diagnostic MR system for cross-sectional and spectroscopic imaging of the labeled head, body, and extremities.

Modality: MRI
Anatomy: Head; body; and extremities
Decision: 2026-05-22

MRI workflow

FDA-cleared K253077

uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.MR provides viewing, manipulation, evaluation, and analysis of MR images, including labeled breast, brain, perfusion, vessel, cardiac, diffusion, susceptibility,...

Modality: MRI
Anatomy: Whole body; brain; breast; vessels; and heart
Decision: 2026-04-22

Breast imaging Cardiac imaging

FDA-cleared K260524

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body; brain; head and neck; heart; lung; breast; gastrointestinal; urinary; genital; and musculoskeletal anatomy
Decision: 2026-04-03

Breast imaging Cardiac imaging Nuclear medicine

FDA-cleared K253564

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body, head and neck, cardiac, and other labeled PET/CT regions
Decision: 2026-02-13

Cardiac imaging Nuclear medicine

FDA-cleared K253173

uCT 780 with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

uCT 780 acquires cross-sectional whole-body CT images, including head, neck, cardiac, and vascular examinations, with labeled low-dose lung-cancer-screening use and uWS-CT-Dual...

Modality: CT/CTA
Anatomy: Whole body, head, neck, heart, vessels, and lungs
Decision: 2026-01-20

Cardiac imaging

FDA-cleared K252371

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

uMR 680 is a 1.5T MRI system that produces transverse, sagittal, coronal, oblique, and spectroscopic images and physical parameters of the head, body, and extremities, including...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2025-09-25

MRI workflow

FDA-cleared K251167

uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd.

uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it...

Modality: X-ray/Radiography
Anatomy: Skull, spine, chest, abdomen, extremities, limbs, and trunk
Decision: 2025-09-19

Breast imaging MSK and bone

FDA-cleared K250246

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd.

uMR Jupiter is a diagnostic MR system for imaging the labeled head, body, and extremities in patients weighing more than 20 kg, with contrast use as applicable to the region.

Modality: MRI
Anatomy: Head; body; and extremities
Decision: 2025-08-05

MRI workflow

FDA-cleared K243547

uMR Ultra

Shanghai United Imaging Healthcare Co., Ltd.

uMR Ultra is a diagnostic MR system for imaging the labeled head, body, and extremities.

Modality: MRI
Anatomy: Head; body; and extremities
Decision: 2025-07-17

MRI workflow

FDA-cleared K251839

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

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,...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body; brain; head and neck; heart; lung; breast; gastrointestinal; urinary; genital; and musculoskeletal anatomy
Decision: 2025-07-17

Breast imaging Radiotherapy planning Cardiac imaging

FDA-cleared K243397

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

uMR 680 is a diagnostic MR system for imaging the labeled head, body, and extremities.

Modality: MRI
Anatomy: Head; body; and extremities
Decision: 2025-07-16

MRI workflow

FDA-cleared K243122

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

uMR Omega is an MR diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and physical parameters...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2025-05-21

MRI workflow

FDA-cleared K243617

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co.,Ltd.

uCT ATLAS Astound and uCT ATLAS are whole-body CT systems for head, body, cardiac, and vascular imaging, with dual-energy analysis options and protocol-governed low-dose...

Modality: CT/CTA
Anatomy: Multi-region
Decision: 2025-05-16

Cardiac imaging

FDA-cleared K242624

Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...

Modality: CT/CTA
Anatomy: Colon, lungs and airway, vessels, brain, heart, liver, ribs, spine, and other CT regions
Decision: 2025-05-14

Cardiac imaging MSK and bone Oncology quantification

FDA-cleared K243376

uAngio AVIVA CX

Shanghai United Imaging Healthcare Co.,Ltd.

uAngio AVIVA CX provides image guidance for diagnostic, interventional, and surgical procedures, including cardiac, neuro, vascular, nonvascular, rotational angiography, and...

Modality: Fluoroscopy/Angiography
Anatomy: Whole body; cardiac, neuro, vascular and non-vascular anatomy
Decision: 2025-04-28

Cardiac imaging

FDA-cleared K241166

uCT 550

Shanghai United Imaging Healthcare Co., Ltd.

uCT 550 is a CT X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including...

Modality: CT/CTA
Anatomy: Whole body, head, neck, cardiac, and vascular anatomy
Decision: 2025-01-14

Cardiac imaging

FDA-cleared K241079

uCT 780

Shanghai United Imaging Healthcare Co., Ltd.

uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and...

Modality: CT/CTA
Anatomy: Multi-region
Decision: 2025-01-07

Cardiac imaging

FDA-cleared K243538

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

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and regional anatomy represented in PET/CT studies
Decision: 2024-12-12

Radiotherapy planning Oncology quantification Detection and CADe

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

Quantification and segmentation Nuclear medicine

FDA-cleared K241596

uMI Panvivo

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and regional anatomy represented in PET/CT studies
Decision: 2024-08-15

Radiotherapy planning Detection and CADe Nuclear medicine

FDA-cleared K234154

uPMR 790

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Head, body, and extremities represented in fused PET/MR studies
Decision: 2024-05-24

Nuclear medicine

FDA-cleared K233209

uOmnispace.CT

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...

Modality: CT/CTA
Anatomy: Colon, jaw, lungs, airways, brain, heart, vessels, liver, spine, ribs, and other labeled CT regions
Decision: 2024-05-17

Cardiac imaging MSK and bone Oncology quantification

FDA-cleared K233673

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd

uMR Jupiter is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images, and physical...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2024-04-26

MRI workflow

FDA-cleared K233186

uOmnispace.MR

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.MR is a software solution for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists MR stitching,...

Modality: MRI
Anatomy: Breast, brain, heart, vessels, and other labeled MR anatomy
Decision: 2024-04-17

Breast imaging Cardiac imaging

FDA-cleared K240744

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

The uMR 680 is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images, spectroscopic images, and physical...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2024-04-10

MRI workflow

FDA-cleared K240540

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd.

The uMR Omega is a magnetic-resonance diagnostic device that produces sagittal, transverse, coronal, and oblique cross-sectional images and spectroscopic images displaying...

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2024-03-22

MRI workflow

FDA-cleared K233176

uOmnispace.MI

Shanghai United Imaging Healthcare Co., Ltd.

uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Multi-region PET, CT, MR, and SPECT examinations including oncology, neurology, cardiology, brain, and cardiac analyses
Decision: 2023-12-20

Cardiac imaging Oncology quantification Quantification and segmentation

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

Oncology quantification Detection and CADe Quantification and segmentation

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

Detection and CADe Quantification and segmentation Nuclear medicine

FDA-cleared K230039

uOmnispace

Shanghai United Imaging Healthcare Co., Ltd

uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Multi-region medical images, excluding U.S. digital mammography diagnosis
Decision: 2023-07-20

Breast imaging

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

Oncology quantification Detection and CADe Quantification and segmentation

FDA-cleared K223028

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

uCT ATLAS Astound is a computed-tomography X-ray system that produces cross-sectional images of the whole body and is applicable to head, whole-body, cardiac, and vascular CT; it...

Modality: CT/CTA
Anatomy: Head, whole body, cardiac, vascular, and lung-screening anatomy
Decision: 2023-02-16

Cardiac imaging

FDA-cleared K220332

uMR Omega with uWS-MR-MRS

Shanghai United Imaging Healthcare Co.,Ltd.

The uMR Omega System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and...

Modality: MRI
Anatomy: Breast
Decision: 2022-10-27

Breast imaging

FDA-cleared K203448

uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

uCT ATLAS with uWS-CT-Dual Energy Analysis supports the labeled CT acquisition, reconstruction, and dual-energy image-analysis workflow for professional interpretation.

Modality: CT/CTA
Anatomy: Multi-region
Decision: 2021-08-11

CT/CTA workflow

FDA-cleared K210001

HYPER AiR

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and organs represented in supported PET/CT studies
Decision: 2021-04-30

Nuclear medicine

FDA-cleared K193210

HYPER DLR

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...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole-body FDG PET images
Decision: 2020-08-04

Nuclear medicine

FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...

Modality: CT/CTA
Anatomy: Adult head, chest, abdomen, cardiac, and vascular CT
Decision: 2020-07-06

Cardiac imaging Detection and CADe

FDA-cleared K192601

uWS-MR

Shanghai United Imaging Healthcare Co., Ltd

uWS-MR provides MR image viewing, manipulation, communication, storage, stitching, fusion, spectroscopy, parameter maps, breast evaluation, brain perfusion, and related processing...

Modality: MRI
Anatomy: Head, body, breast, brain, and other anatomy represented in supported MR examinations
Decision: 2020-06-01

Breast imaging

FDA-cleared K193176

uMR 780

Shanghai United Imaging Healthcare Co., Ltd

uMR 780 MRDD produces cross-sectional, oblique, and spectroscopic MR images and physical parameters of the head, body, and extremities for interpretation by trained physicians.

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2020-05-05

MRI workflow