Cartesion Prime (PCD-1000A/3)

by Canon Medical Systems Corporation  · Based in Japan → — Navigate to personalized care with a well-balanced digital PET/CT scanner.
Nuclear Medicine Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Cartesion Prime (PCD-1000A/3) is a premium digital PET/CT scanner developed by Canon Medical Systems Corporation, designed to enhance clinical insights and maximize business performance. It leverages innovative Silicon Photo-Multiplier (SiPM) technology with one-to-one crystal coupling and 100% crystal coverage to deliver exceptional image quality and accurate quantification.

A key feature is its 100% air-cooled technology, which significantly reduces the complexity and cost associated with traditional water-cooled systems, including siting requirements, chiller needs, and overall maintenance. The system boasts a large 27 cm axial field of view (FOV) and fast Time-of-Flight (TOF) resolution (e.g., 263 ps typical), contributing to faster scans, optimized dose efficiency, and a more comfortable patient experience.

Cartesion Prime integrates AI-assisted reconstruction through Canon’s Advanced intelligent Clear-IQ Engine (AiCE) for both PET and CT, which uses deep learning technology to distinguish true signal from noise, improving image quality, signal-to-noise ratio (SNR), and quantification accuracy. It also includes Motion Management with PET Deviceless Data-Driven Respiratory Gating for automated motion correction. The system is designed for streamlined workflow, improved throughput, and a patient-centric experience, featuring a wide 78 cm bore and flared-gantry design.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Digital PET/CT scanner with Silicon Photo-Multiplier (SiPM) technology
  • One-to-one crystal-SiPM coupling and 100% crystal coverage
  • Large 27 cm axial field of view (FOV)
  • Fast Time-of-Flight (TOF) resolution (e.g., 263 ps typical)
  • 100% air-cooled technology for reduced siting complexity and cost
  • AI-assisted reconstruction: Advanced intelligent Clear-IQ Engine (AiCE) for PET and CT
  • Motion Management with PET Deviceless Data-Driven Respiratory Gating
  • Optimized dose and reduced scan times
  • Streamlined workflow and improved throughput
  • Wide 78 cm bore and flared-gantry design for enhanced patient comfort

Use Cases

  • Oncology imaging and lesion detection
  • Metabolic and physiologic function assessment
  • Cardiac imaging and assessment
  • Brain imaging
  • Whole-body PET/CT scans for comprehensive diagnostics
  • Enhanced clinical insights and personalized patient care

What Physicians Need to Know

Key Capabilities
Combines high-end CT (Aquilion Prime SP) and high-throughput digital PET with SiPM sensors. Features AiCE (Advanced intelligent Clear-IQ Engine) deep learning reconstruction for both PET and CT, improving image quality and reducing noise. Includes a Deviceless PET Respiratory-gating system for motion correction. Offers fast Time-of-Flight (TOF) resolution (<250 ps typical) and a large 27 cm axial Field of View (FOV). Designed for dose reduction and metal artifact reduction.
Clinical Utility
Aids in the evaluation, detection, localization, diagnosis, staging, restaging, follow-up, and therapeutic planning/outcome assessment of oncological, cardiovascular, and neurological diseases. Provides superior image quality with minimal noise, accurate quantification, and faster scan times, enhancing diagnostic confidence and the ability to detect smaller lesions, particularly in areas affected by respiratory motion. Supports prostate cancer assessment with PSMA PET imaging.
Integration Options
Designed to acquire and fuse CT and PET images. DICOM conformance statements are available to facilitate checking compatibility and integrating the system within a DICOM compliant hospital network.
Compliance Status
FDA 510(k) cleared as a Class II medical device (K231748, K203314, K251370). Conforms to 21 CFR 892.1750 (Computed Tomography X-ray System) and 21 CFR u00a7892.1200 (Emission Computed Tomography System). Manufactured under Quality System Regulations (21 CFR u00a7 820) and ISO 13485 Standards, and complies with applicable IEC and NEMA standards.
User Experience
Features a patient-centric design with a wide 78 cm bore, flared gantry, wide patient couch, and low minimum bed height for enhanced comfort and easier patient access. An operator-centric design includes features like Tech-Assist Lateral Slide to reduce operator radiation exposure and streamline workflow. The user interface is described as having a good layout, being easy to navigate, and offering streamlined image processing with fewer steps.
Support Quality
Canon Medical Systems provides comprehensive support, with one customer reporting exceptional service from project management to installation, maintenance, applications, and ongoing support.
Implementation Complexity
Features a compact room design (22.4 mu00b2) and 100% air-cooling technology, eliminating the need for a chiller and reducing the complexities and costs associated with water-cooled systems and larger installation spaces. This allows for easier siting in existing PET rooms.
Evidence Base
Supported by bench tests demonstrating improved image quality, quantification accuracy, and signal-to-noise ratio. Clinical studies involving patients show comparable or superior image quality with reduced PET dose and scan times compared to previous generation systems. Physician evaluations confirm diagnostic quality and improved performance with deviceless respiratory gating.
Physician Tip

Leverage the AiCE deep learning reconstruction for superior image quality and reduced noise, which can improve diagnostic confidence, especially for subtle lesions. Utilize the Deviceless PET Respiratory-gating system to enhance image quality in areas affected by respiratory motion without external devices. The patient-centric design, including the wide bore and comfortable couch, can significantly improve patient experience and compliance, potentially leading to better throughput. Consider the air-cooling and compact footprint for easier integration into existing or smaller imaging suites.

The Cartesion Prime (PCD-1000A/3) is a combined PET/CT system, inherently integrating these two imaging modalities. Its DICOM conformance ensures compatibility with standard hospital imaging networks (PACS, EMR) for seamless image transfer and data management. Specific integrations with advanced visualization platforms or AI-driven post-processing tools beyond its built-in AiCE are likely supported via DICOM, but should be verified with Canon Medical Systems.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing — Contact vendor for details
DeploymentOn-premise (physical scanner)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cartesion Prime (PCD-1000A/3) V10.21 received FDA 510(k) clearance (K251370) on December 1, 2025, as a substantially equivalent computed tomography emission system.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

The Canon Medical Systems Cartesion Prime (PCD-1000A/3) is a diagnostic imaging system that integrates high-end CT and high-throughput PET capabilities to acquire CT, PET, and fusion images. Physicians with extensive experience in nuclear medicine have evaluated its performance, particularly its AiCE (Advanced intelligent Clear-IQ Engine) technology, reporting diagnostic quality images with improved sharpness and overall image quality. The system is designed for a wide range of diagnostic applications, including oncology, cardiology, and neurology, and can also function independently as a multi-slice CT scanner.

Overall: Positive

Strengths

  • Combines high-end CT and high-throughput PET for comprehensive imaging.
  • Utilizes digital PET detectors with SiPM sensors for excellent temporal resolution.
  • AiCE technology enhances image quality, sharpness, and reduces noise in PET images.
  • Images are consistently of diagnostic quality across various settings and cases.
  • Can be operated independently as a whole-body multi-slice CT scanner.
  • Assists in evaluation, detection, diagnosis, staging, and treatment assessment of various diseases.

Limitations

  • Specific cons were not identified in the provided search results.
  • Detailed user reviews from platforms like Reddit, G2, or Capterra were not found.
  • Information on pricing and compliance posture is not readily available in public summaries.

Based on reviews from: Canon Medical Systems Corporation (FDA Submissions), accessdata.fda.gov, Radiology AI Tools Directory, Scribd (Artificial Intelligence and Machine Learning (AIML) - Enabled Medical Devices FDA), Canon Medical Systems - Physician Ai Tools, FDA Product Classification (KPS), BINASSS (18F-FDG PET/CT for Response Assessment in Lung Cancer), FDA 510(k) Premarket Notification, Sheet1 (FDA 510(k) clearances), BEUDAMED

Last updated: 2026-07-17

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Press & Coverage

FDA
K231748 - 510(k) Premarket Notification - FDA
This FDA premarket notification details the clearance of Cartesion Prime (PCD-1000A/3) V10.15 by Canon Medical Systems Corporation on September 12, 2023. The device is a combined high-end CT and high-throughput PET system intended for acquiring CT, PET, and fusion images to detect positron-emitting radiopharmaceuticals in the body.
2023-09
Predicase (referencing Canon Medical Systems)
Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems ...
Cartesion Prime (PCD-1000A/3) V10.21 is an FDA-cleared radiology AI listing for PET/SPECT/Nuclear Medicine. This version was cleared on December 1, 2025, and includes enhancements like pediatric AiCE-i and a Deviceless PET Respiratory gating system.
2025-12
FDA
December 1, 2025 Canon Medical Systems Corporation Yoshiaki Cook Sr. Manager, Regulatory Affairs Canon Medical Systems, USA
This FDA document outlines the substantial equivalence determination for Cartesion Prime (PCD-1000A/3) V10.21, cleared on December 1, 2025. The device is a diagnostic imaging system combining PET and CT for oncological, cardiovascular, and neurological diseases.
2025-12
Predicase
Cartesion Prime (PCD-1000A/3) V10.21 (K251370) u2014 FDA 510(k) Clearance | Predicase
This article from Predicase details the FDA 510(k) clearance of Cartesion Prime (PCD-1000A/3) V10.21 on December 1, 2025. It highlights the device's intended use for PET/CT imaging in various diseases and its new features, including pediatric AiCE-i and Deviceless PET Respiratory gating.
2205-12
HaRi
Cartesion Prime (PCD-1000A/3) V10.21
HaRi lists Cartesion Prime (PCD-1000A/3) V10.21 as a regulatory-cleared device by Canon Medical Systems Corporation, intended for use by trained healthcare professionals.
unknown
FDA.report
CANON INC. FDA Filings - FDA.report
This FDA.report listing shows Canon Inc.'s FDA filings, including the Cartesion Prime (PCD-1000A/3) V10.21 with a clearance date of December 2025, and the V10.8 version cleared in April 2021.
2025-12
FDA.report
KPS u00b7 System, Tomography, Computed, Emission u2014 FDA Product ...
The FDA Product Code KPS, which stands for 'System, Tomography, Computed, Emission,' includes the Cartesion Prime (PCD-1000A/3) V10.21 from Canon.
unknown

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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