510(k) clearances

uPMR 790

Shanghai United Imaging Healthcare Co., Ltd. · Radiology

K234154Substantially EquivalentTraditionalOUO
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Third party flag
N
City
Shanghai
Advisory committee description
Radiology
Address 1
#2258 Chengbei Rd. Jiading District
Statement or summary
Summary
Product code
OUO
Zip code
201807
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Decision date
2024-05-24
Decision code
SESE
Country code
CN
Device name
uPMR 790
Advisory committee
RA
Contact
Xin Gao
K number
K234154
Date received
2023-12-29
Review advisory committee
RA
Postal code
201807
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical specialty description
Radiology
Regulation number
892.1200
Device class
2
Registration number
3004754211, 3011015597, 1529041, 3015329423, 3015232217, 3012085143, 3011950073, 2183553, 2247992, 3005326970, 3002808157, 3010949642
FEI number
1000208827, 3004754211, 3011015597, 3005214683, 3015329423, 3015232217, 3012085143, 3011950073, 2183553, 3005326970, 3002808157, 3010949642
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.