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Polymer Patient Examination Glove
407
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351
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299
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283
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Automated Radiological Image...
275
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269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
208
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Shanghai United Imaging Intelligence Co., Ltd.
Medical Device Manufacturer
·
CN , Shanghai
Shanghai United Imaging Intelligence Co., Ltd. - FDA 510(k) Cleared D...
4 submissions
·
4 cleared
·
Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shanghai United Imaging Intelligence Co., Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 24, 2024
uAI Easy Triage ICH
K242292
·
QAS
Radiology
·
53d
Cleared
Sep 06, 2024
uAI Portal
K240411
·
QIH
Radiology
·
207d
Cleared
Feb 16, 2023
uMR 680
K222755
·
LNH
Radiology
·
157d
Cleared
Jan 15, 2021
uAI EasyTriage-Rib
K193271
·
QFM
Radiology
·
416d
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4
Radiology
4