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Gendex VixWin™ imaging software 3

by Gendex Corp.

Gendex VixWin™ imaging software 3 (VIXWINPL) is a Class II device made by Gendex Corp., cleared under FDA 510(k) K060178 on 10 Mar 2006 and listed in FDA GUDID since 14 Apr 2017 (UDI-DI EKAV101037680), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K060178

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEKAV101037680 UDI-DI Date14 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060178 Date10 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060178 decided 10 Mar 2006 Active
  • FDA GUDID UDI-DI EKAV101037680 listed 14 Apr 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1548-2009 FDA Unclassified (pre-2012) initiated 6 Mar 2009 on shared 510(k) K060178

    There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K060178
  2. Recall initiated FDA recalls Z-1548-2009
  3. Listed FDA GUDID EKAV101037680

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gendex VixWin™ imaging software
Generic name
Radiology information system application software
Model / Ref / Catalog
3, VIXWINPL
Primary DI / UDI-DI
EKAV101037680
510(k) Number
FDA product code
LLZ
GMDN term
Radiology information system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology information system application software

Similar devices

Other devices filed under FDA product code LLZ (System, image processing, radiological).

Other devices from Gendex Corp.

See all devices from Gendex Corp. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)