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510(k) K191939

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2019
Date Received
July 19, 2019
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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