MrDraw

FDA UDI

Class II (US FDA UDI)

by Koelis

Identity

Trade Name: MrDraw FDA UDI
Generic Name: Image segmentation application software FDA UDI
Device Name: 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 FDA UDI
Model / Reference: KURO-4000 FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 03665134000929 FDA UDI
510(k) Number: K170521 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Image segmentation application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Image segmentation application software

MrDraw by Koelis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K170521 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Koelis

Sources (1)

FDA UDI 243d568e-5fc5-484c-988a-21513306a9d8 35 fields · synced Jun 8, 2026