uPMR 790

K234154

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-05-24 · product code OUO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc.”

AlgorithmDeep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution (DeepRecon); acceleration reconstruction technique with AI module (ACS).

source quote (p.13)

“DeepRecon is a deep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.12)

“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (3)

Retrospective clinical

n=165,837 cases

endpoints: equivalence to uMR Omega; SNR; resolution; image qualities (contrast and uniformity)

Retrospective clinical

n=35 cases

endpoints: SNR; resolution; image qualities (contrast and uniformity); equivalence to uMR Omega; structure measurements

Bench

sample size not stated

endpoints: verify that the proposed device met all design specifications

Reported performance (1 observation)

accuracyas written: “Accuracy (maximum value of the bias)”stated without value

source quote (p.9)

“maximum value of the bias at or below necr peak activity value: ≤10%”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).