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VMA VMA3000 Control Console Assembly

by Driving Force Company GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 28 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860015011107 UDI-DIDate2 Jan 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-2889-2018 FDA Class II initiated 23 May 2018

    This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.

    • Ongoing Z-2891-2018 FDA Class II initiated 2 Mar 2017

    Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.

    • Ongoing Z-2882-2018 FDA Class II initiated 11 Jan 2017

    Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.

    • Ongoing Z-2890-2018 FDA Class II initiated 12 Aug 2016

    Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

Specification

GUDID

Trade Name
Vma
Generic Name
Diagnostic x-ray digital imaging system workstation
Model / Ref / Catalog
VMA3000 Control Console Assembly, VMA3000
Primary DI / UDI-DI
00860015011107
510(k) Number
FDA Product Code
LLZ
GMDN Term
Diagnostic x-ray digital imaging system workstation
Device Class
Class II
Regulation Number
892.2050
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K112109)

Cleared under the same submission (K130743)

Cleared under the same submission (K133875)

Other devices from Driving Force Company

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No