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510(k) K250211

Yushan X-Ray Flat Panel Detector by Innocare Optoelectronics Corp. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
January 24, 2025
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

Other clearances by Innocare Optoelectronics Corp.

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  • K201528 — Yushan X-Ray Flat Panel Detector with DROC (October 11, 2020)
  • K191939 — Yushan X-Ray Flat Panel Detector (August 29, 2019)

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