uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

K251839

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-07-17 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The proposed device uMI Panvivo combines a 295/235 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. The system includes PET system, CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories. Deep MAC, Deep Learning-based Metal Artifact Correction (also named AI MAC) is an image reconstruction algorithm that combines physical beam hardening correction and deep learning technology.”
AlgorithmDeepRecon.PET is an image post-processing technique which uses a pre-trained neural network. uExcel DPR is a PET reconstruction algorithm based on deep learning method, utilizing pre-trained deep neural networks. OncoFocus uses two deep-learning-based AI networks (CNN-BC and CNN-AC). DeepMAC is an image post-processing technology that uses pre-trained neural networks.
source quote (p.10)
“DeepRecon.PET is an image post-processing technique which uses a pre-trained neural network to reduce noise and improve image quality. uExcel DPR is a PET reconstruction algorithm based on deep learning method. It utilizes pre-trained deep neural networks on long-axis datasets to optimize the iterative reconstruction process, effectively reducing noise and improving contrast. There are two deep-learning-based AI networks in OncoFocus, one is the body cavity segmentation network (CNN-BC) for respiratory signal generation, and the other is the attenuation map (umap) synthesis network (CNN-AC) for more accurate attenuation correction and image registration. DeepMAC is an image post-processing technology that uses pre-trained neural networks to reduce metal artifacts and improve image quality.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (4)

Retrospective clinical

n=20 patients

endpoints: Image consistency (bias); Image background noise (BV, SNR); Image contrast to noise ratio (CNR)

standards: NEMA NU 2-2018

Retrospective clinical

n=19 patients

endpoints: Contrast recovery (CR); background variability (BV); contrast-to-noise ratio (CNR)

standards: NEMA NU 2-2018

Retrospective clinical

n=50 patients

endpoints: Volume relative to no motion correction (AVolume); Maximal standardized uptake value relative to no motion correction (ASUVmax)

Retrospective clinical

n=20 patients

endpoints: Average CT value in the affected area of the metal substance and the same area of the control image before and after DeepMAC was compared.

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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
5
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253564 (decision 2026-02-13) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253564

  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2023-03-01

    Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

    recall event 91870 (openFDA)

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2022-05-30

    The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

    recall event 90888 (openFDA)

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2021-08-02

    The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

    recall event 88521 (openFDA)

  • Recalling firm matches this device's applicant (Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China) — same firm and product code, not necessarily this device · initiated 2021-08-02

    The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

    recall event 88521 (openFDA)

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/K251839