FDA-cleared K193176
uMR 780
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-05-05
Vendor
Shanghai United Imaging Healthcare Co., Ltd
34 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K192601
uWS-MR
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-06-01
FDA-cleared K193073
Deep Recon
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-07-06
FDA-cleared K193210
HYPER DLR
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2020-08-04
FDA-cleared K210001
HYPER AiR
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-04-30
FDA-cleared K203448
uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-08-11
FDA-cleared K220332
uMR Omega with uWS-MR-MRS
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-10-27
FDA-cleared K223028
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-02-16
FDA-cleared K223325
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-03-10
FDA-cleared K230039
uOmnispace
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2023-07-20
FDA-cleared K231572
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-07-26
FDA-cleared K232712
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-10-03
FDA-cleared K233176
uOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2023-12-20
FDA-cleared K240540
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-03-22
FDA-cleared K240744
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-10
FDA-cleared K233186
uOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-17
FDA-cleared K233673
uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-04-26
FDA-cleared K233209
uOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-05-17
FDA-cleared K234154
uPMR 790
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-05-24
FDA-cleared K241596
uMI Panvivo
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-08-15
FDA-cleared K241585
uMI Panorama
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-08-30
FDA-cleared K243538
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2024-12-12
FDA-cleared K241079
uCT 780
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-07
FDA-cleared K241166
uCT 550
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-14
FDA-cleared K243376
uAngio AVIVA CX
Shanghai United Imaging Healthcare Co.,Ltd.
Image analysis/processing for Vascular using Fluoroscopy/Angiography.
- Modality
- Fluoroscopy/Angiography
- Anatomy
- Vascular
- Decision
- 2025-04-28
FDA-cleared K242624
Medical Image Post-processing Software (uOmnispace.CT)
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-14
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.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-16
FDA-cleared K243122
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K243397
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-16
FDA-cleared K243547
uMR Ultra
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-07-17
FDA-cleared K251839
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-07-17
FDA-cleared K250246
uMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-08-05
FDA-cleared K251167
uDR Aurora CX
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-09-19
FDA-cleared K252371
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-25