Class Class II

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239)

K242239 2024-08-16 Special
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Description

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) by Gentuity, LLC — FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242239
Clearance Date2024-08-16
Clearance TypeSpecial
Product CodeNQQ
Regulation Number892.1560

Categories

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