FDA 510(k) clearance · back to tracker

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

Gentuity, LLC cleared K242966 on 2025-01-31, decision: substantially equivalent

K-number

K242966

Sponsor

Gentuity, LLC

Device

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-01-31

Product code

DQO

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1200

Official FDA record

Open K242966on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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