uOmnispace— 510(k) K230039

Name: FDA 510(k) clearance K230039
Creator: U.S. Food and Drug Administration
Published: 2023-07-20

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K230039 for uOmnispace, Substantially Equivalent on 2023-07-20. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-01-06
Decision date: 2023-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

view all

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Shanghai United Imaging Healthcare Co., Ltd.

view all

K253726 — uAngio AVIVA CX2026-08-21
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K260113 — uMR Astra2026-05-22
K253077 — uOmnispace.MR2026-04-22
K260524 — uMI Panvivo (5 models)2026-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.