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510(k) K202572

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2020
Date Received
September 4, 2020
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

Other clearances by DRGEM Corporation

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  • K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) (September 19, 2023)
  • 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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  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
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  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)