Aurora
K251153GE Medical Systems Israel · cleared 2025-06-12 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use. GE HealthCare's (GEHC) subject Aurora device is a modification to the predicate Aurora (K243605) device by adding a new deep-learning Automatic Kidney Segmentation algorithm to the "Realtime Time Activity Curve" software feature cleared under Aurora system (K243605).”
source quote (p.6)
“GE HealthCare's (GEHC) subject Aurora device is a modification to the predicate Aurora (K243605) device by adding a new deep-learning Automatic Kidney Segmentation algorithm to the "Realtime Time Activity Curve" software feature cleared under Aurora system (K243605).”
Validation studies (2)
Bench
n=70 images · 3 site(s)
endpoints: DICE similarity score
Reader study (MRMC)
n=70 cases
endpoints: quality of the segmentation using a 4-point Likert scale
Reported performance (1 observation)
source quote (p.9)
“The DL Automatic kidney produced an average DICE score above the predefined success criteria.”
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).