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Will3D

by Hdx Will Corp.

Will3D is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K170180 on 8 May 2017, registered in EUDAMED and listed in FDA GUDID since 22 Dec 2017 (UDI-DI 08800005200144), active as of 23 Oct 2026.

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

CE MDR 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) K170180

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 Number08800005200144 UDI-DI Date22 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK170180 Date8 May 2017IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K170180 decided 8 May 2017 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 08800005200144 listed 22 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170180
  2. Listed FDA GUDID 08800005200144

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Radiological PACS-dedicated management software
Model / reference
Will3D
Primary DI / UDI-DI
08800005200144
510(k) Number
FDA product code
LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from Hdx Will Corp.

  • WillCeph Pro

    Class IIa
  • Xcam

    Class II
  • DENTRI Max DENTRI-Sα

    Class II
  • DENTRIα Series

    Class II

See all devices from Hdx Will Corp. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)