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510(k) K183292

Topaz Mobile DR System by DRGEM Corporation — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2019
Date Received
November 26, 2018
Clearance Type
Traditional
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

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  • 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)
  • K182537 — RADMAX Digital Imaging Software (March 8, 2019)

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