Cartesion Prime (PCD-1000A/3) V10.15— 510(k) K231748

Name: FDA 510(k) clearance K231748
Creator: U.S. Food and Drug Administration
Published: 2023-09-12

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K231748 for Cartesion Prime (PCD-1000A/3) V10.15, Substantially Equivalent on 2023-09-12. Applicant: Canon Medical Systems Corporation. Device class: 2.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2023-06-15
Decision date: 2023-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K231748

K-number listed on FDA's recall record

Z-0284-2025 — Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.Class II·Ongoing·Canon Medical System, USA, INC.·20240917

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231748.

Data sourced from openFDA. This site is unofficial and independent of the FDA.