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510(k) K220579

Hybrid C70 by Digimed Co., Ltd. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2022
Date Received
February 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Digimed Co., Ltd.

  • K221587 — DHX-70H, XTG-70H (March 3, 2023)
  • K220574 — HYBRID S70 (April 22, 2022)
  • K181891 — Portable X-ray System (Model: MiniX-V, Mini X-S) (August 10, 2018)

Other clearances for product code EHD

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  • K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (September 4, 2025)
  • K242185 — Rextar Pro (December 4, 2024)
  • K242591 — XERO-alpha (November 1, 2024)
  • K241963 — WERAY (July 30, 2024)
  • K241305 — LifeRay Intraoral Handheld X-ray System (July 5, 2024)
  • K240759 — REMEX-GR100 (May 13, 2024)
  • K233914 — XVbeam2000 (February 8, 2024)