# K223144: Galaxy System

- Pathway: 510(k) (Traditional)
- Applicant: Noah Medical Corp.
- Decided: Mar 1, 2023 after 148 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955065 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173760: Monarch Endoscopy Platform (Monarch Platform), Auris Surgical Robotics, Inc. (2018) Summary page 4.

## Recalls of this device
- Sep 12, 2025 · Class II · Z-0598-2026: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
- Oct 28, 2024 · Class II · Z-0742-2025: Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. 
- Oct 25, 2024 · Class II · Z-0679-2025: Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-de
- Oct 25, 2024 · Class II · Z-0693-2025: Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occ
- Mar 9, 2024 · Class II · Z-1734-2024: Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

## Indications for use
The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K223144
Methodology: https://510kreport.com/methodology