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510(k) K162518

1012WCC, 1012WGC by Rayence Co., Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2016
Date Received
September 9, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (March 18, 2025)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)