Home / 510(k) Clearances / K182622

510(k) K182622

GU60A, GU60A-65 by Samsung Electronics Co., Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2018
Date Received
September 24, 2018
Clearance Type
Special
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

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  • K201560 — Auto Lung Nodule Detection (August 31, 2021)

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  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)