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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 K250211
Device Name Yushan X-Ray Flat Panel Detector
Applicant
Innocare Optoelectronics Corp.
Rm. B, # 2, Sec. 2, Huanxi Rd., Southern Taiwan Science
Park, Xinshi Dist.
Tainan,  TW 741
Applicant Contact Christy Huang
Correspondent
Innocare Optoelectronics Corp.
Rm. B, # 2, Sec. 2, Huanxi Rd., Southern Taiwan Science
Park, Xinshi Dist.
Tainan,  TW 741
Correspondent Contact Christy Huang
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/24/2025
Decision Date 07/22/2025
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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