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MR Draw Kuro-4000

by Koelis

MR Draw Kuro-4000 is a Class II device made by Koelis, listed in FDA GUDID since 23 Jul 2020 (UDI-DI 03665134000578), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03665134000578 UDI-DI Date23 Jul 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
MR Draw
Generic name
Image segmentation application software
Model / reference
KURO-4000
Primary DI / UDI-DI
03665134000578
FDA product code
LLZ
GMDN term
Image segmentation application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Koelis

See all devices from Koelis →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)