uMI Panorama
K231572Shanghai United Imaging Healthcare Co., Ltd. · cleared 2023-07-26 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The proposed device uMI Panorama GS combines a 148 cm axial field of view (FOV) PET and multi-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET gantry, CT gantry, patient table, power supply cabinet, console and reconstruction system, chiller, vital signal module.”
source quote (p.7)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
Validation studies (1)
Bench
sample size not stated
endpoints: verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device.
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), 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K241585 (decision 2024-08-30) from Shanghai United Imaging Healthcare Co.,Ltd. for a matching device line ("uMI Panorama") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241585
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232712 (decision 2023-10-03) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMI Panorama") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232712
- 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).