Company profile

Shanghai United Imaging Healthcare Co., Ltd.

Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled medical devices on the FDA list. The first decision was on May 5, 2020 and the most recent on May 22, 2026 (uMR Astra). Its most common review panel is Radiology (33 devices).

33AI devices

2020First decision

2026Latest decision

1Specialties

Per year

202020212023202420252026

Shanghai United Imaging Healthcare Co., Ltd. AI devices per year: 2020 4, 2021 1, 2023 6, 2024 7, 2025 10, 2026 5

By specialty

Radiology33

Timeline

May 22, 2026 · 510(k) K260113uMR Astra · Radiology · LNH
April 22, 2026 · 510(k) K253077uOmnispace.MR · Radiology · QIH
April 3, 2026 · 510(k) K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) · Radiology · KPS
February 13, 2026 · 510(k) K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) · Radiology · KPS
January 20, 2026 · 510(k) K253173uCT 780 with uWS-CT-Dual Energy Analysis · Radiology · JAK
September 25, 2025 · 510(k) K252371uMR 680 · Radiology · LNH
September 19, 2025 · 510(k) K251167uDR Aurora CX · Radiology · KPR
August 5, 2025 · 510(k) K250246uMR Jupiter · Radiology · LNH
July 17, 2025 · 510(k) K243547uMR Ultra · Radiology · LNH
July 17, 2025 · 510(k) K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) · Radiology · KPS
July 16, 2025 · 510(k) K243397uMR 680 · Radiology · LNH
May 21, 2025 · 510(k) K243122uMR Omega · Radiology · LNH
May 14, 2025 · 510(k) K242624Medical Image Post-processing Software (uOmnispace.CT) · Radiology · QIH
January 14, 2025 · 510(k) K241166uCT 550 · Radiology · JAK
January 7, 2025 · 510(k) K241079uCT 780 · Radiology · JAK
August 15, 2024 · 510(k) K241596uMI Panvivo · Radiology · KPS
May 24, 2024 · 510(k) K234154uPMR 790 · Radiology · OUO
May 17, 2024 · 510(k) K233209uOmnispace.CT · Radiology · QIH
April 26, 2024 · 510(k) K233673uMR Jupiter · Radiology · LNH
April 17, 2024 · 510(k) K233186uOmnispace.MR · Radiology · QIH
April 10, 2024 · 510(k) K240744uMR 680 · Radiology · LNH
March 22, 2024 · 510(k) K240540uMR Omega · Radiology · LNH
December 20, 2023 · 510(k) K233176uOmnispace.MI · Radiology · LLZ
October 3, 2023 · 510(k) K232712uMI Panorama · Radiology · KPS
July 26, 2023 · 510(k) K231572uMI Panorama · Radiology · KPS
July 20, 2023 · 510(k) K230039uOmnispace · Radiology · QIH
March 10, 2023 · 510(k) K223325uMI Panorama · Radiology · KPS
February 16, 2023 · 510(k) K223028uCT ATLAS Astound with uWS-CT-Dual Energy Analysis · Radiology · JAK
August 11, 2021 · 510(k) K203448uCT ATLAS with uWS-CT-Dual Energy Analysis · Radiology · JAK
August 4, 2020 · 510(k) K193210HYPER DLR · Radiology · KPS
July 6, 2020 · 510(k) K193073Deep Recon · Radiology · JAK
June 1, 2020 · 510(k) K192601uWS-MR · Radiology · QIH
May 5, 2020 · 510(k) K193176uMR 780 · Radiology · LNH