uMI Panorama
K232712Shanghai United Imaging Healthcare Co., Ltd. · cleared 2023-10-03 · product code KPS · Radiology
Premarket evidence — what FDA accepted
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 (K223325) in this submission are due to the algorithm update of uExcel Focus (also named OncoFocus) and the addition of uKinetics. This time, uExcel Focus adds deep learning technology based on the original technology and could be performed as intended.”
source quote (p.5)
“uExcel Focus adds deep learning technology based on the original technology and could be performed as intended.”
source quote (p.7)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
Validation studies (4)
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 XR 25-2019, Computed Tomography Dose Check, NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT, NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management, IEC 61223-3-5 2004 Edition 1.0, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)], NEMA NU 2-2018, Performance Measurements of Positron Emission Tomographs, 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 10993-5: 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, Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Bench
sample size not stated
endpoints: Volume relative to no motion correction (AVolume); Maximum standardized uptake value relative to no motion correction (ASUVmax); Mean standardized uptake value relative to no motion correction (ASUVmean)
Bench
sample size not stated
endpoints: Bias of area under curve (AUC) of the estimated image-derived input function (IDIF); Bias of Ki and intercept in the hot spheres in the IQ phantom; Coefficient of variation (CoV) of the background region in the IQ phantom
Reader study (MRMC)
sample size not stated
endpoints: all images produced by uMI Panorama with uExcel Focus are sufficient for clinical diagnosis and uExcel Focus can reduce attenuation correction artifacts and improve PET-CT alignment
Reported performance (2 observations)
source quote (p.8)
“The performance evaluation showed that uExcel Focus could reduce respiratory motion effects and improve the accuracy of SUV and lesion volume in comparison with no motion correction.”
source quote (p.8)
“Bias of area under curve (AUC) of the estimated image-derived input function (IDIF).”
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
- 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).