uMI Panorama

K241585

Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2024-08-30 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The uMI Panorama is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The mainly modifications performed on the uMI Panorama GS (K231572) in this submission are due to the algorithm update of AIIR, the addition of HYPER Iterative, uExcel DPR, RMC, AIEFOV, Motion Management, CT-less AC, uKinetics, Retrospective Respiratory-gated Scan, uExcel Unity and uExcel iQC.”
Algorithmdeep learning (DL) network from a variational network to a three-dimension deep convolutional neural network (3D-DCNN); regularized iterative reconstruction algorithm; pre-trained neural networks; AI-based algorithm; deep learning technology
source quote (p.5)
“AIIR in this submission changed its deep learning (DL) network from a variational network to a three-dimension deep convolutional neural network (3D-DCNN). HYPER Iterative (cleared via K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function. uExcel DPR (also named HYPER AiR, cleared via K210001) incorporates pre-trained neural networks in the iteration reconstruction process to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images. RMC, Respiratory Motion Correct (also named uExcel Focus or OncoFocus, cleared via K232712) is an AI-based algorithm to reduce respiratory motion artifacts in PET/CT images and at the same time reduce the PET/CT misalignment. AIEFOV is an extended field of view algorithm connecting projection data extrapolation and deep learning. CT-less AC is developed with deep learning technology to achieve PET AC without CT images.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (2)

Bench

sample size not stated

standards: ANSI/AAMIES60601-1: 2005/ (R) 2012+A1:2012+C1: 2009/(R)2012+A2:2010/(R)2012)[IncludingAmendment2(2021)]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC60601-1-2: 2014+A1:200, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-3: 2008+AMD1:2013+A2:2021, Edition 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment., IEC 60601-2-44: 2009+A1:2012+A2:2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography, IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements., IEC 60601-1-6: 2010+A1:2013+A2:2020, Edition 3.2, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability., IEC 62304: 2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes, NEMA NU 2-2018, Performance Measurements of Positron Emission Tomographs, NEMA PS 3.1-3.20(2022d): Digital Imaging and Communications in Medicine (DICOM), ISO 10993-1: 2018, Edition 5.0, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process., ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity., ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization., ISO 14971: 2019, Edition 3.0, Medical Devices – Application of risk management to medical devices, Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation, Code of Federal Regulations, Title 21, Subchapter J - Radiological Health

Retrospective clinical

n=13 patients

endpoints: image Artifacts; homogeneity of same tissue; diagnostic confidence in PET 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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
4
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

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/K241585