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

System, Tomography, Computed, Emission

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Cartesion Prime (pcd-1000a/3) V10.8.

Pre-market Notification Details

Device IDK203314
510k NumberK203314
Device Name:Cartesion Prime (PCD-1000A/3) V10.8
ClassificationSystem, Tomography, Computed, Emission
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo, Jr.
Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin,  CA  92780
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-10
Decision Date2021-04-23

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