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510(k) Data Aggregation

K Number

Device Name

OPUSWAVE Dual Sensor Imaging System

Manufacturer

Terumo Cardiovascular Systems THI Plant

Date Cleared

2025-07-02

(118 days)

Product Code

NQQ

Regulation Number

892.1560

Why did this record match?

Applicant Name (Manufacturer) :

Terumo Cardiovascular Systems THI Plant

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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