MR DRAW

GUDID 03665134000585

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.

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
Primary Device ID03665134000585
NIH Device Record Key30bfdfe2-e521-4457-8f66-a2ff1dc41fe9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR DRAW
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
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000578 [Primary]
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution
GS103665134000585 [Package]
Contains: 03665134000578
Package: cardboard [1 Units]
In Commercial Distribution

FDA Product Code

LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
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 Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by KOELIS

03665134000585 - MR DRAW2020-07-31A 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.
03665134000585 - MR DRAW2020-07-31 A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest
03665134000059 - Reusable guide2020-07-27 The device concerned is a metallic guide designed to be plugged on an endocavity ultrasound probe, to guide a linear instrument
03665134000110 - transP - Reusable Guid Perine Grid 18G2020-07-27 PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides gu
03665134000172 - transP - Reusable Guid Perine Nail 14G2020-07-27 PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides gu
03665134000141 - transP - perine full grid 18G2020-07-27 The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. PERINE range guides are made
03665134000134 - transP - perine full grid 14G2020-07-27 The guides from PERINE range are intended to guide a needle during ultrasound-guided intervention. PERINE range guides are made
03665134000202 - transP - Perine Adaptater 2020-07-27 PERINE range guides are made up of one part fixed on the ultrasound probe, which enables needle guiding. PERINE range guides gu
03665134000592 - Steady Pro2020-07-27 Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably maintain the position of a transr

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