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510(k) K203659

iSR'obot Mona Lisa 1.0 by Biobot Surgical Pte., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
December 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Biobot Surgical Pte., Ltd.

  • K232320 — iSR`obot Mona Lisa 2.0 (December 21, 2023)
  • K213411 — iSR’obot Mona Lisa 2.0 (December 22, 2021)
  • K163502 — iSR'obot Biopsy Kit (May 16, 2017)
  • K161109 — iSR'obot MRI-US Fusion (October 6, 2016)
  • K130944 — ISR'OBOT MONA LISA (June 7, 2013)
  • K111347 — ISROBOT MONA LISA (August 12, 2011)

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