Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter— 510(k) K242966

Substantially Equivalent

Gentuity, LLC

FDA 510(k) clearance K242966 for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter, Substantially Equivalent on 2025-01-31. Applicant: Gentuity, LLC.

Clearance details

Applicant: Gentuity, LLC
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2024-09-26
Decision date: 2025-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sudbury, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.