Omni Legend
K241665GE Medical Systems Israel, Functional Imaging · cleared 2024-08-08 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“GE HealthCare's subject Omni Legend device, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GEHC Positron Emission Tomography (PET) System and a current production diagnostic GEHC Computed Tomography (CT) System. The proposed Omni Legend is a conventional, general-purpose PET/CT system using existing technological characteristics with identical Intended Use and Indications for Use as its predicate. Image Reconstruction / Processing: Iterative Image Reconstruction, including Precision DL (K223212).”
source quote (p.8)
“Image Reconstruction / Processing: Iterative Image Reconstruction, including Precision DL (K223212). PET Digital Gating (DDG) also known as MotionFree (K180318) Enhanced AC option”
Validation studies (2)
Bench
sample size not stated
endpoints: Risk Analysis; Required Reviews; Design Reviews; Testing on unit level (Module verification); Integration testing (System verification); Performance testing (Verification); Safety testing (Verification); Simulated use testing (Validation); System Sensitivity; Noise Equivalent Count Rate (NECR); Contrast Recovery and Contrast to Noise Ratio; Spatial Resolution; Quantitation; Dose / Time Reduction (Acquisition and Image Quality); Design for Scalability; substantiation of PET Digital Gating cleared performance claims; qualitative and quantitative evaluation of PET images corrected with Enhanced AC; demonstration of improvement in lesion quantitation
standards: 21CFR 820, ISO 13485, IEC 60601-1, IEC 60601-1-2, 60601-1-3, 60601-2-44, NEMA NU 2-2018
Reader study (MRMC)
sample size not stated
endpoints: assessment of overall diagnostic image quality using a Likert Scale; ability of Enhanced AC to correct artifacts
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 matches this device's applicant.
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 matches this device's applicant.
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).