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Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) & PMA Approved Devices — 84 products

Total Devices84
Categories10
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
510(k) K193241 Emission Computed Tomography SystemKPS2020-01-26 View
510(k) K183144 uMC 560iOWB2019-12-19 View
510(k) K192672 uPMR 790OUO2019-11-20 View
510(k) K192293 uDR 592h, uDR 596iKPR2019-09-12 View
510(k) K183170 uWS-CTLLZ2019-06-24 View
510(k) K191157 uMR 780, uMR 790LNH2019-05-29 View
510(k) K183164 uWS-MRLLZ2019-03-22 View
510(k) K183014 uPMR 790OUO2019-02-27 View
510(k) K183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24MOS2019-02-08 View
510(k) K183137 uMR 580, uMR 588LNH2019-01-11 View
510(k) K182938 Emission Computed Tomography SystemKPS2018-12-18 View
510(k) K173001 uWS-CTLLZ2018-11-07 View
510(k) K172999 uWS-MRLLZ2018-11-07 View
510(k) K182237 uMI 550 PET/CT SystemKPS2018-10-12 View
510(k) K181371 uMR 790LNH2018-10-03 View
510(k) K181370 uMR 780LNH2018-10-03 View
510(k) K181414 uCT 530, uCT 550JAK2018-08-14 View
510(k) K181413 uDR 592h, uDR 596iKPR2018-06-27 View
510(k) K180926 uMR 560LNH2018-06-06 View
510(k) K180925 uMR 570LNH2018-06-06 View

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