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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 K161109
Device Name iSR'obot MRI-US Fusion
Applicant
Biobot Surgical Pte., Ltd.
2 Woodlands Spectrum 1,
#03-10, Woodlands Sector 1
Singapore,  SG 738068
Applicant Contact Lai Chee LIEW
Correspondent
Biobot Surgical Pte., Ltd.
2 Woodlands Spectrum 1,
#03-10, Woodlands Sector 1
Singapore,  SG 738068
Correspondent Contact Lai Chee LIEW
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2016
Decision Date 10/06/2016
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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