Emission Computed Tomography System— 510(k) K182938

Clearance details

Applicant

Shanghai United Imaging Healthcare Co., Ltd.

Product code

Code KPS

Device class

Class 2

Regulation

21 CFR 892.1200

Advisory panel

Radiology

Date received

2018-10-23

Decision date

2018-12-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

• K261305 — MICSI-PET2026-09-11
• K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
• K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
• K260524 — uMI Panvivo (5 models)2026-04-03
• K253564 — uMI Panvivo (4 models)2026-02-13

• K253726 — uAngio AVIVA CX2026-08-21
• K260113 — uMR Astra2026-05-22
• K253077 — uOmnispace.MR2026-04-22
• K253173 — uCT 780 with uWS-CT-Dual Energy Analysis2026-01-20
• K252000 — uDR Arria & uDR Aris2025-11-26

• Z-2799-2020 — uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.Class II·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·20200716

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182938.