Galaxy System

GUDID 00850048825048

The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable bronchoscope under continuous and direct control by a physician operator. The Galaxy System™ includes full procedure navigation that integrates a pre-operative computed tomography scan to display scope tip location relative to the pre-operative scan anatomy. Additionally, Galaxy integrates a tomosynthesis spin to update the scope and target position to overcome any changes in anatomy not reflected in the pre-op CT scan.

Noah Medical Corporation

Flexible video bronchoscope, reusable

• Primary Device ID: 00850048825048
• NIH Device Record Key: 5f93f03d-7c6f-4cfb-afce-2d65882b510c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy System
• Version Model Number: GAL-001
• Company DUNS: 117566482
• Company Name: Noah Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00850048825048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223144

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

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: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [Galaxy System]

• 00000850048825: The Galaxy System is designed with the intent to enable articulation and precise control of a fl
• 00850048825048: The Galaxy System is designed with the intent to enable articulation and precise control of a fl