Cartesion Prime (PCD-1000A/3) V10.8

K203314

Canon Medical Systems Corporation · cleared 2021-04-23 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. ... 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. The AiCE algorithm will be able to better differentiate signal from noise and can be applied to improve image quality and denoising of PET images.”
Algorithmdeep learning artificial neural network methods
source quote (p.5)
“employing deep learning artificial neural network methods which can more fully explore the statistical properties of the signal and noise of PET data. The AiCE algorithm will be able to better differentiate signal from noise and can be applied to improve image quality and denoising of PET images.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“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 (8)

Bench

sample size not stated

endpoints: image quality; quantification accuracy; count dependency; preservation of quantification; Signal to Noise Ratio; average SUV; activity concentration of the image

Bench

sample size not stated

endpoints: Contrast Recovery Coefficient (CRC); Background Variability (BGV); Lung Residual Error

standards: NEMA NU 2-2018

Bench

sample size not stated

endpoints: does not create any artifacts

Bench

sample size not stated

endpoints: higher contrast

Bench

sample size not stated

endpoints: Background mean; Sum of SUV of the sphere slice; Sum of SUV of the entire IEC Body Phantom

Retrospective clinical

sample size not stated

endpoints: creates no artifact

Retrospective clinical

sample size not stated

endpoints: Peak Signal to Noise Ratio (PSNR)

Reader study (MRMC)

n=5 patients

endpoints: diagnostic quality; Overall image quality; image sharpness; image noise

Reported performance (1 observation)

accuracyas written: “quantification accuracy”stated without value
source quote (p.7)
“A series of bench tests were conducted to support marketing claims associated with image quality, quantification accuracy, count dependency, and preservation of quantification.”

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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
6
drift signals on this device
  • 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231748 (decision 2023-09-12) from Canon Medical Systems Corporation for a matching device line ("Cartesion Prime (PCD-1000A/3) V10.15") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231748

  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K203314