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510(k) K242019

GXR-Series Diagnostic X-Ray System by DRGEM Corporation — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2025
Date Received
July 10, 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 DRGEM Corporation

  • K251443 — PROMO (August 22, 2025)
  • K242015 — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (December 16, 2024)
  • K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (September 19, 2023)
  • 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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  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)
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