FDA 510(k) clearance · back to tracker

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

Gentuity, LLC cleared K230620 on 2023-08-08, decision: substantially equivalent

K-number

K230620

Sponsor

Gentuity, LLC

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-08-08

Product code

DQO

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1200

Official FDA record

Open K230620on 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.

Use this as a predicate

Drop K230620 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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