uMI Panorama
K241585Shanghai United Imaging Healthcare Co.,Ltd. · cleared 2024-08-30 · 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. 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.”
source quote (p.6)
“AIIR in this submission changed its deep learning (DL) network from a variational network to a three-dimension deep convolutional neural network (3D-DCNN).”
source quote (p.8)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
Validation studies (2)
Bench
sample size not stated
endpoints: improve the accuracy of CT value; improve the accuracy and uniformity of PET image SUV by performing attenuation correction with CT generated with AIEFOV algorithm when scanned object exceed CT field of view; consistent CT value; consistent PET image SUV by performing attenuation correction with CT generated with AIEFOV algorithm when scanned object does not exceed the CT field of view
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
- 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).