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

Cleared Aug 21, 2026

uAngio AVIVA CX

K253726 · OWB

Radiology · 270d

Cleared Jul 28, 2026

uMI Panvivo (uMI Panvivo M)

K261427 · KPS

Radiology · 89d

Cleared May 22, 2026

uMR Astra

K260113 · LNH

Radiology · 128d

Cleared Apr 22, 2026

uOmnispace.MR

K253077 · QIH

Radiology · 211d

Cleared Apr 03, 2026

uMI Panvivo (uMI Panvivo LS)

K260524 · KPS

Radiology · 45d

Cleared Feb 13, 2026

uMI Panvivo (uMI Panvivo)

K253564 · KPS

Radiology · 88d

Cleared Jan 20, 2026

uCT 780 with uWS-CT-Dual Energy Analysis

K253173 · JAK

Radiology · 116d

Cleared Nov 26, 2025

uDR Arria & uDR Aris

K252000 · KPR

Radiology · 152d

Cleared Sep 25, 2025

uMR 680

K252371 · LNH

Radiology · 57d

Cleared Sep 24, 2025

uWS-Angio Pro

K250045 · LLZ

Radiology · 257d

Cleared Sep 19, 2025

uDR Aurora CX

K251167 · KPR

Radiology · 157d

Cleared Sep 12, 2025

uWS-Angio

K250040 · LLZ

Radiology · 247d