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) and an acceleration reconstruction technique with a regularization term from 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. ACS is an acceleration reconstruction technique. By adding one more regularization term from Al module, ACS is a slight extension of CS (Compressed Sensing).”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (3)

Standalone

sample size not stated

endpoints: SNR and resolution; contrast and uniformity

Standalone

n=15 patients

endpoints: SNR and resolution; contrast and uniformity

Reader study (MRMC)

sample size not stated

endpoints: diagnostic quality images

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

1
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K234154