Cartesion Prime (PCD-1000A/3) V10.15
K231748Canon Medical Systems Corporation · cleared 2023-09-12 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The subject device incorporates the latest reconstruction technology, AiCE-i for PET (Advanced Intelligent Clear-IQ Engine- integrated), intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can more fully explore the statistical properties of the signal and noise of PET data.”
source quote (p.6)
“employing deep learning artificial neural network methods which can more fully explore the statistical properties of the signal and noise of PET data.”
source quote (p.7)
“The method of operation and manufacturing process for the Cartesion Prime remain unchanged from the cleared device.”
source quote (p.9)
“Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014, is also included as part of this submission.”
Validation studies (2)
Bench
sample size not stated
endpoints: accuracy of SUV (max and mean); tumor volume
Retrospective clinical
n=10 patients
endpoints: diagnostic quality; better or same performance as non-gated images or device-based gated images
Reported performance (1 observation)
source quote (p.9)
“This system has been demonstrated to be substantially equivalent to the current method of respiratory gating, using an external device, and, with respect to quantitative parameters such as accuracy of SUV (max and mean) and tumor volume, is improved over the current device-based gating method.”
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) K251370 (decision 2025-12-01) from Canon Medical Systems Corporation for a matching device line ("Cartesion Prime (PCD-1000A/3) V10.21") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251370
- 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).