Home / 510(k) Clearances / K180543

510(k) K180543

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 by Samsung Electronics Co., Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2018
Date Received
March 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Samsung Electronics Co., Ltd.

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  • K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
  • K222353 — GM85 (September 29, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K220175 — GM85 (April 21, 2022)
  • K211139 — CUBE Air Purifier (November 26, 2021)
  • K201560 — Auto Lung Nodule Detection (August 31, 2021)

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  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
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  • K242119 — INNOVISION-EXII (January 3, 2025)
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