Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

40 submissions · 39 cleared · Since 2013

40

Total

39

Cleared

1

Denied

FDA 510(k) cleared devices by Samsung Electronics Co., Ltd. Radiology ✕

33 devices

1-12 of 33

Cleared Oct 01, 2024

Radiology · 27d

Cleared Sep 19, 2024

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

Radiology · 29d

Cleared Sep 29, 2022

Radiology · 56d

Cleared Apr 21, 2022

Radiology · 90d

Cleared Aug 31, 2021

Auto Lung Nodule Detection

Radiology · 447d

Cleared Dec 07, 2018

GC70, GU60A, GU60A-65, GF50, GR50A

Radiology · 116d

Cleared Oct 24, 2018

Radiology · 30d

Cleared Oct 23, 2018

GU60A, GU60A-65

Radiology · 29d

Cleared Jul 20, 2018

Digital Diagnostic Mobile X-ray System

Radiology · 30d

Cleared Jul 20, 2018

Radiology · 30d

Cleared Jul 20, 2018

Radiology · 30d

Cleared May 24, 2018

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

Radiology · 84d