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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Cartesion Prime (PCD-1000A/3) V10.21

Manufacturer

Canon Medical Systems Corporation

Date Cleared

2025-12-01

(213 days)

Product Code

Regulation Number

Type

Panel

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N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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