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510(k) K232178

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) by DRGEM Corporation — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2023
Date Received
July 24, 2023
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 DRGEM Corporation

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  • K202572 — GXR-Series Diagnostic X-Ray System (September 24, 2020)
  • K202156 — DIAMOND-5A/6A/8A (September 10, 2020)
  • K201124 — TOPAZ Mobile DR System (May 19, 2020)
  • K192453 — DIAMOND-5A/6A/8A (October 1, 2019)
  • K192364 — GXR-Series Diagnostic X-Ray System (September 26, 2019)
  • K183292 — Topaz Mobile DR System (May 15, 2019)
  • K182537 — RADMAX Digital Imaging Software (March 8, 2019)

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  • 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)