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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K254214
Device Name OOOPDS
Applicant
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
2f., # 41, Keya Rd., Daya Dist
Taiwan (R.O.C.)
Taichung,  TW 428015
Applicant Contact Jacky Fan
Correspondent
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
2f., # 41, Keya Rd., Daya Dist
Taiwan (R.O.C.)
Taichung,  TW 428015
Correspondent Contact Jacky Fan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/29/2025
Decision Date 09/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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