Medical Device Manufacturer · CN , Shanghai

Shanghai United Imaging Healthcare Co., Ltd. - FDA 510(k) Cleared Dev...

80 submissions · 80 cleared · Since 2018
80
Total
80
Cleared
0
Denied
80 devices
51-75 of 80
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Radiology · 262d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Radiology · 255d
Cleared May 05, 2020
uMR 780
K193176 · LNH
Radiology · 169d
Cleared Apr 20, 2020
uMR 570
K200024 · LNH
Radiology · 105d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Radiology · 128d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Radiology · 53d
Cleared Jan 26, 2020
Emission Computed Tomography System
K193241 · KPS
Radiology · 62d
Cleared Dec 19, 2019
uMC 560i
K183144 · OWB
Radiology · 401d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Radiology · 55d
Cleared Sep 12, 2019
uDR 592h, uDR 596i
K192293 · KPR
Radiology · 20d
Cleared Jun 24, 2019
uWS-CT
K183170 · LLZ
Radiology · 220d
Cleared May 29, 2019
uMR 780, uMR 790
K191157 · LNH
Radiology · 28d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Radiology · 127d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Radiology · 119d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Radiology · 81d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Radiology · 59d
Cleared Dec 18, 2018
Emission Computed Tomography System
K182938 · KPS
Radiology · 56d
Cleared Nov 07, 2018
uWS-MR
K172999 · LLZ
Radiology · 406d
Cleared Nov 07, 2018
uWS-CT
K173001 · LLZ
Radiology · 406d
Cleared Oct 12, 2018
uMI 550 PET/CT System
K182237 · KPS
Radiology · 56d
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Radiology · 133d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Radiology · 133d
Cleared Aug 14, 2018
uCT 530, uCT 550
K181414 · JAK
Radiology · 76d
Cleared Jun 27, 2018
uDR 592h, uDR 596i
K181413 · KPR
Radiology · 28d
Cleared Jun 06, 2018
uMR 570
K180925 · LNH
Radiology · 58d

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