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510(k) K220239

Solid State X-ray Imager(Model: FXRD-4386WB) by Vieworks Co., Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2022
Date Received
January 28, 2022
Clearance Type
Traditional
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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  • K190611 — VIVIX-S 1751S (April 8, 2019)
  • K181003 — VIVIX-S 1717V (May 15, 2018)
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Other clearances for product code MQB

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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)