Medical Device Manufacturer · US , Alexandria , VA

Biobot Surgical Pte., Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2011

Recent clearances: iSR`obot Mona Lisa 2.0, iSR’obot Mona Lisa 2.0, iSR'obot Mona Lisa 1.0

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biobot Surgical Pte., Ltd. Radiology ✕

7 devices

1-7 of 7

Cleared Dec 21, 2023

iSR`obot Mona Lisa 2.0

Radiology · 140d

Cleared Dec 22, 2021

iSR’obot Mona Lisa 2.0

Radiology · 64d

Cleared Jul 08, 2021

iSR'obot Mona Lisa 1.0

Radiology · 205d

Cleared May 16, 2017

iSR'obot Biopsy Kit

Radiology · 153d

Cleared Oct 06, 2016

iSR'obot MRI-US Fusion

Radiology · 169d

Cleared Jun 07, 2013

ISR'OBOT MONA LISA

Radiology · 64d

Cleared Aug 12, 2011

ISROBOT MONA LISA

Radiology · 91d