MrDraw

GUDID 03665134000929

A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a

KOELIS

Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software
Primary Device ID03665134000929
NIH Device Record Key243d568e-5fc5-484c-988a-21513306a9d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMrDraw
Version Model NumberKURO-4000
Company DUNS290318455
Company NameKOELIS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103665134000929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

Devices Manufactured by KOELIS

03665134000929 - MrDraw2023-10-10A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a
03665134000929 - MrDraw2023-10-10 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest
03665134000509 - 3D End-Fire Endocavity Probe2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
03665134000516 - 3D Side-Fire Endocavity Probe2023-04-13 Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3
03665134000523 - 2D Abdominal Probe2023-04-13 Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
03665134000530 - 2D Linear Probe2023-04-13 Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gy
03665134000189 - CON LEAD 14G2023-04-13 Needle guide compatible with the abdominal 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound pro
03665134000301 - LIN LEAD 18G2023-04-13 Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe.
03665134000318 - LIN LEAD 14G2023-04-13 Needle guide compatible with the linear 2D ultrasound probe. It is made of two parts. One part is fixed on the ultrasound probe.
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