510(k) K234154

uPMR 790 by Shanghai United Imaging Healthcare Co., Ltd. — Product Code OUO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2024
Date Received: December 29, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device Class: Class II
Regulation Number: 892.1200
Review Panel: RA
Submission Type

Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.

Other clearances by Shanghai United Imaging Healthcare Co., Ltd.

K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo (February 13, 2026)
K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
K252000 — uDR Arria & uDR Aris (November 26, 2025)
K252371 — uMR 680 (September 25, 2025)
K250045 — uWS-Angio Pro (September 24, 2025)
K251167 — uDR Aurora CX (September 19, 2025)
K250040 — uWS-Angio (September 12, 2025)
K250246 — uMR Jupiter (August 5, 2025)
K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
K243547 — uMR Ultra (July 17, 2025)

Other clearances for product code OUO

K253023 — BIOGRAPH One (January 15, 2026)
K222540 — uPMR 790 (November 14, 2022)
K213709 — SIGNA PET/MR (January 20, 2022)
K200213 — Biograph mMR with syngo MR E11P-AP01 system software (May 11, 2020)
K192672 — uPMR 790 (November 20, 2019)
K183014 — uPMR 790 (February 27, 2019)
K172531 — Biograph mMR with mMR Angio Transfer Option (November 14, 2017)
K163234 — Biograph mMR with syngo MR E11P system software (February 28, 2017)
K163619 — SIGNA PET/MR (February 14, 2017)
K142098 — SIGNA PET/MR (November 24, 2014)