FDA.reportPublic FDA data

iSR'obot Mona Lisa

Primary DI
08885014610382
Brand
iSR'obot Mona Lisa
Company
BIOBOT SURGICAL PTE. LTD.
Model
iSR'obot Mona Lisa 2.0
Published
2024-02-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
LLZSystem, Image Processing, Radiological
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
OIJBiopsy Needle Guide KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885014610382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885014610382088850146103828885014610382

GMDN Terms#

Term, Definition table
TermDefinition
Prostate stereotactic biopsy/ablation systemAn assembly of electrically-powered devices intended to be used for trajectory planning and positioning of interventional instruments during computer-assisted transperineal prostate biopsy and ablation procedures under image-guidance, using real-time ultrasound imaging and pre-acquired MRI scans. It consists of a software-assisted console with a screen interface and a robotic electromechanical arm designed to guide the surgical instrument (e.g., prostate needle) to the target site following the pre-planned path set by the physician.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595137775
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885014610023iSR'obot Biopsy KitiSR'obot Biopsy KitG4AA6102024-06-14
08885014610184iSR'obot KitiSR'obot Kit - 13GAS-000064162024-06-14
08885014610207iSR'obot KitiSR'obot Kit - 14GAS-000057862024-06-14
08885014610221iSR'obot KitiSR'obot Kit - 17GAS-000064152024-06-14
08885014610245iSR'obot KitiSR'obot Kit - 18GAS-000057872024-02-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
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00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01