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510(k) K201124

TOPAZ Mobile DR System by DRGEM Corporation — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2020
Date Received
April 27, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by DRGEM Corporation

  • K251443 — PROMO (August 22, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 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)
  • 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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