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510(k) K260085

RAYMO Mobile X-ray System (Model: RAYMO) by DRGEM Corporation — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2026
Date Received
January 12, 2026
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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  • 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)

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