SubtlePET
K182336Subtle Medical, Inc. · cleared 2018-11-30 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG) and amyloid PET images (including PET/CT and PET/MRI).”
source quote (p.5)
“The SubtlePET image processing software reduces noise to increase image quality using a deep neural network-based algorithm. The software employs a convolutional neural network-based method in a pixel's neighborhood to generate the value for each pixel. Using a residual learning approach, the software predicts the noise components and structural components. The software separates these components, which enhances the structure while simultaneously reducing the noise.”
source quote (p.7)
“both algorithms are fixed image-domain nonlinear filtering that uses neighborhood information, and both methods have optimized parameters to ensure robustness and adaption to variable structures, tissues, noises and scales.”
Validation studies (1)
Bench
sample size not stated
endpoints: significant average increase in quantitative metrics for all cases demonstrating that the software reduced noise in PET scans
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) K211964 (decision 2021-09-28) from Subtle Medical, Inc. for a matching device line ("SubtlePET") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211964
- 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).