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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K201528
Device Name Yushan X-Ray Flat Panel Detector with DROC
Applicant
InnoCare Optoelectronics Corp.
Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist.,
Tainan City 744, Taiwan (R.O.C.)
Tainan City,  TW 744
Applicant Contact Yumei Cheng
Correspondent
InnoCare Optoelectronics Corp.
Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist.,
Tainan City 744, Taiwan (R.O.C.)
Tainan City,  TW 744
Correspondent Contact Yumei Cheng
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/08/2020
Decision Date 10/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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