Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd.

40 submissions · 39 cleared · Since 2013

40

Total

39

Cleared

1

Denied

Samsung Electronics Co., Ltd. — FDA 510(k) Submissions

Samsung Electronics Co., Ltd. has submitted 40 FDA 510(k) premarket notifications since 2013, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Stationary, System, X-ray, Mobile, Solid State X-ray Imager (flat Panel/digital Imager), Electrocardiograph Software For Over-the-counter Use, Purifier, Air, Ultraviolet, Medical . Use the specialty filter in the sidebar to narrow results.

40 devices

1–25 of 40

K242651 · IZL System, X-ray, Mobile · Radiology

GF85 (models GF85-3P, GF85-SP)

K242478 · KPR System, X-ray, Stationary · Radiology

Samsung ECG App v 1.3 (ECG)

K240909 · QDA Electrocardiograph... · Cardiovascular

Sleep Apnea Feature

DEN230041 · QZW Over-the-counter Device... · Anesthesiology

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

K230292 · QDA Electrocardiograph... · Cardiovascular

K222353 · IZL System, X-ray, Mobile · Radiology

K213452 · PHL Powered Exoskeleton · Neurology

K220175 · IZL System, X-ray, Mobile · Radiology

CUBE Air Purifier

K211139 · FRA Purifier, Air,... · General Hospital

Auto Lung Nodule Detection

K201560 · MYN Analyzer, Medical Image · Radiology

ECG Monitor App

K201168 · QDA Electrocardiograph... · Cardiovascular

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

K182183 · KPR System, X-ray, Stationary · Radiology

K182647 · KPR System, X-ray, Stationary · Radiology

GU60A, GU60A-65

K182622 · KPR System, X-ray, Stationary · Radiology

Digital Diagnostic Mobile X-ray System

K181626 · IZL System, X-ray, Mobile · Radiology

K181629 · KPR System, X-ray, Stationary · Radiology

K181631 · MQB Solid State X-ray Imager... · Radiology

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

K180543 · KPR System, X-ray, Stationary · Radiology

GU60A & GU60A-65

K173828 · KPR System, X-ray, Stationary · Radiology

K172229 · KPR System, X-ray, Stationary · Radiology

K171119 · IZL System, X-ray, Mobile · Radiology

K163115 · KPR System, X-ray, Stationary · Radiology

Digital Diagnostic Mobile X-ray System

K162278 · IZL System, X-ray, Mobile · Radiology

K160997 · KPR System, X-ray, Stationary · Radiology

K153401 · MQB Solid State X-ray Imager... · Radiology