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

K243538

Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2024-12-12 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (1)

Bench

sample size not stated

standards: ANSI/AAMI ES60601-1: 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, IEC 60601-1-2:2014+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, IEC TR 60601-4-2:2016, Edition 1.0, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 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

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
6
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251839 (decision 2025-07-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251839

  • 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/K243538