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."
1–24 of 86
Search insights Median review: 133d Cleared: 100% Top manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Lead specialty: Radiology
Cleared Oct 28, 2026
uPMR Zenith
K261676 · OUO
Shanghai United Imaging Healthcare...
Radiology · 160d
Cleared Aug 21, 2026
uAngio AVIVA CX
K253726 · OWB
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Jul 28, 2026
uMI Panvivo (uMI Panvivo M)
K261427 · KPS
Shanghai United Imaging Healthcare...
Radiology · 89d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 03, 2026
uMI Panvivo (uMI Panvivo LS)
K260524 · KPS
Shanghai United Imaging Healthcare...
Radiology · 45d
Cleared Feb 13, 2026
uMI Panvivo (uMI Panvivo)
K253564 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Jan 20, 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · JAK
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Sep 25, 2025
uMR 680
K252371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Aug 05, 2025
uMR Jupiter
K250246 · LNH
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Jul 17, 2025
uMI Panvivo (uMI Panvivo)
K251839 · KPS
Shanghai United Imaging Healthcare...
Radiology · 31d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 16, 2025
uMR 680
K243397 · LNH
Shanghai United Imaging Healthcare...
Radiology · 258d
Cleared Jun 17, 2025
uOmniscan
K243666 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 202d
Cleared May 21, 2025
uMR Omega
K243122 · LNH
Shanghai United Imaging Healthcare...
Radiology · 233d
Cleared May 16, 2025
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · JAK
Shanghai United Imaging Healthcare...
Radiology · 175d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 12, 2025
uWS-Angio Basic
K243632 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 168d
Cleared Apr 28, 2025
uAngio AVIVA CX
K243376 · OWB
Shanghai United Imaging Healthcare...
Radiology · 180d
Cleared Jan 14, 2025
uCT 550
K241166 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d