Gentuity HF-OCT Imaging System

GUDID 00859910007032

Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.

GENTUITY LLC

Coronary optical coherence tomography system

• Primary Device ID: 00859910007032
• NIH Device Record Key: 3b234111-fd59-4d4f-a982-61ef523303ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentuity HF-OCT Imaging System
• Version Model Number: Gentuity Imaging System G10-01 K192922
• Company DUNS: 077509759
• Company Name: GENTUITY LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859910007032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192922

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-30
• Device Publish Date: 2021-06-22

Devices Manufactured by GENTUITY LLC

• 00859910007049 - Gentuity: 2022-08-25 Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.
• 00859910007032 - Gentuity HF-OCT Imaging System: 2021-06-30Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
• 00859910007032 - Gentuity HF-OCT Imaging System: 2021-06-30 Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/
• 00859910007018 - Vis-Rx: 2021-02-19 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US