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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 K191939
Device Name Yushan X-Ray Flat Panel Detector
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 Received07/19/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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