FDA 510(k) clearance · back to tracker

OPUSWAVE Dual Sensor Imaging System

Terumo Cardiovascular Systems Thi Plant cleared K250684 on 2025-07-02, decision: substantially equivalent

K-number

K250684

Sponsor

Terumo Cardiovascular Systems Thi Plant

Device

OPUSWAVE Dual Sensor Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-07-02

Product code

NQQ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1560

Official FDA record

Open K250684on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.