Medical Device Manufacturer · US , Echo , OR

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

43 submissions · 42 cleared · Since 2013

Official Website

Total

Cleared

Denied

43 devices

26-43 of 43

Cleared Nov 15, 2016

Digital Diagnostic Mobile X-ray System

GM60A-32S & GM60A-40S

K150097 · IZL

Radiology · 30d

Cleared Feb 04, 2015

Digital Diagnostic X-ray System (GC80)

Cardiovascular · 146d

Cleared Jun 20, 2013

DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Samsung Research America, Inc.

Mdlab, Inc.

Samsung Research America

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 05, 2026

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

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