FDA 510(k) Applications Submitted by CHRIS PAULIK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K211161 |
04/19/2021 |
Critical Care Suite with Endotracheal Tube Positing AI algorithm |
GE Medical Systems, LLC |
| K191699 |
06/25/2019 |
Discovery XR656 HD with VolumeRad |
GE Hualun Medical Systems Co., Ltd |
| K182234 |
08/17/2018 |
Optima XR240amx |
GE Medical Systems, LLC |
| K142383 |
08/26/2014 |
Optima XR200amx, Optima XR220amx |
GE Medical Systems, LLC |
| K162990 |
10/27/2016 |
Optima XR240amx |
GE Medical Systems, LLC |
| K173602 |
11/21/2017 |
Optima XR240amx, AutoGrid |
GE Medical Systems, LLC |
| K223491 |
11/21/2022 |
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite |
GE Medical Systems, LLC |
| K133664 |
11/29/2013 |
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN |
| K103633 |
12/13/2010 |
ACHILLES |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
| K103730 |
12/21/2010 |
GE LUNAR VISCERAL FAT SOFTWARE |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
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