Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

86 results for "Shanghai United Imaging Healthcare Co., Ltd."
49–72 of 86
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Lead specialty: Radiology
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
Cleared Sep 30, 2022
uDR 380i Pro
K222339 · IZL
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Aug 04, 2020
HYPER DLR
K193210 · KPS
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Jul 06, 2020
uMR570
K201540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Jul 06, 2020
Deep Recon
K193073 · JAK
Shanghai United Imaging Healthcare...
Radiology · 245d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d
Cleared May 05, 2020
uMR 780
K193176 · LNH
Shanghai United Imaging Healthcare...
Radiology · 169d
Cleared Apr 20, 2020
uMR 570
K200024 · LNH
Shanghai United Imaging Healthcare...
Radiology · 105d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016 · JAK
Shanghai United Imaging Healthcare...
Radiology · 53d
Cleared Jan 26, 2020
Emission Computed Tomography System
K193241 · KPS
Shanghai United Imaging Healthcare...
Radiology · 62d
Cleared Dec 19, 2019
uMC 560i
K183144 · OWB
Shanghai United Imaging Healthcare...
Radiology · 401d
Cleared Nov 20, 2019
uPMR 790
K192672 · OUO
Shanghai United Imaging Healthcare...
Radiology · 55d
Cleared Sep 12, 2019
uDR 592h, uDR 596i
K192293 · KPR
Shanghai United Imaging Healthcare...
Radiology · 20d
Cleared Jun 24, 2019
uWS-CT
K183170 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 220d
Cleared May 29, 2019
uMR 780, uMR 790
K191157 · LNH
Shanghai United Imaging Healthcare...
Radiology · 28d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 127d
Cleared Feb 27, 2019
uPMR 790
K183014 · OUO
Shanghai United Imaging Healthcare...
Radiology · 119d
Cleared Feb 08, 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint...
K183186 · MOS
Shanghai United Imaging Healthcare...
Radiology · 81d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d