Home / 510(k) Clearances / K242478

510(k) K242478

GF85 (models GF85-3P, GF85-SP) by Samsung Electronics Co., Ltd. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2024
Date Received
August 21, 2024
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.

  • K242651 — GM85 (October 1, 2024)
  • K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
  • DEN230041 — Sleep Apnea Feature (February 6, 2024)
  • K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
  • K222353 — GM85 (September 29, 2022)
  • K220175 — GM85 (April 21, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K211139 — CUBE Air Purifier (November 26, 2021)
  • K201560 — Auto Lung Nodule Detection (August 31, 2021)
  • K201168 — ECG Monitor App (August 4, 2020)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • 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)