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Limbus Contour 1.4.0

by Limbus Ai Inc.

Limbus Contour 1.4.0 is a Class II device made by Limbus Ai Inc., cleared under FDA 510(k) K201232 on 13 Aug 2020, registered in EUDAMED and listed in FDA GUDID since 9 Jun 2021 (UDI-DI 00628011382146), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201232

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00628011382146 UDI-DI Date9 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK201232 Date13 Aug 2020IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K201232 decided 13 Aug 2020 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 00628011382146 listed 9 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201232
  2. Listed FDA GUDID 00628011382146

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Limbus Contour
Generic name
Radiation therapy software
Model / reference
1.4.0
Primary DI / UDI-DI
00628011382146
510(k) Number
FDA product code
LLZ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Cleared under the same submission (K201232)

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Limbus Ai Inc.

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)