uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

K253564

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2026-02-13 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The proposed device uMI Panvivo combines a 295/235/534/712 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience.”

Algorithmdeep learning-based PET reconstruction algorithm, pre-trained neural networks to reduce metal artifacts, and motion correction techniques

source quote (p.15)

“uExcel DPR (Deep Progressive Reconstruction) is a deep learning-based PET reconstruction algorithm. It utilizes pre-trained deep neural networks on long-axis datasets to optimize the iterative reconstruction process, effectively reducing noise and improving contrast.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.14)

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

Validation studies (5)

Reader study (MRMC)

n=20 patients

endpoints: average CT value in the affected area of the metal substance; tissue interpretability; metal artifacts correction

Reader study (MRMC)

n=8 patients

endpoints: Contrast recovery (CR); background variability (BV); contrast-to-noise ratio (CNR); liver signal-to-noise ratio (liverSNR); visual assessments

standards: NEMA NU 2-2018

Reader study (MRMC)

n=13 patients

endpoints: Volume relative to no respiratory motion correction (∆Volume); Maximal standardized uptake value relative to no respiratory motion correction (∆SUVmax); respiratory motion artifacts; PET/CT alignment accuracy; diagnostic confidence

Reader study (MRMC)

n=7 patients

endpoints: ∆SUVmean in the high-uptake region; head motion artifacts; image quality; diagnostic confidence

Reader study (MRMC)

n=4 patients

endpoints: image Artifacts; homogeneity of same tissue; diagnostic confidence in PET images; accuracy of CT value; accuracy and uniformity of PET image SUV

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-72%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel, initiated 2025-12-24): "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98269
recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel, initiated 2025-06-20): "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector mo" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97193
recall_reason_pattern
Software/algorithm-related recall in product code KPS (Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden, initiated 2024-10-31): "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95673
recall_reason_pattern
Software/algorithm-related recall in product code KPS (Canon Medical System, USA, INC., initiated 2024-09-17): "When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95471

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).