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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K232320
Device Name iSR`obot Mona Lisa 2.0
Applicant
Biobot Surgical Pte., Ltd.
79 Ayer Rajah Crescent, #04-05
Singapore,  SG 139955
Applicant Contact Lim Yan Shin
Correspondent
Biobot Surgical Pte., Ltd.
79 Ayer Rajah Crescent, #04-05
Singapore,  SG 139955
Correspondent Contact Lim Yan Shin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   LLZ   OIJ  
Date Received08/03/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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