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Instatrak

by Visualization Technology, Inc.

510(k) K960330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960330 Date8 Apr 1996ClearedStatusActive

Recalls

9 recalls · FDA

    • Terminated Z-0524-2014 FDA Class II initiated 26 Nov 2013

    GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

    • Terminated Z-2251-2012 FDA Class I initiated 22 Jun 2009

    GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.

    • Terminated Z-0183-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007

    Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

    • Terminated Z-1130-2007 FDA Unclassified (pre-2012) initiated 18 May 2007

    Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.

  • 2 recalls, same reason

    • Terminated Z-0688-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004
    • Terminated Z-0687-05 FDA Unclassified (pre-2012) initiated 13 Dec 2004

    Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

  • 3 recalls, same reason

    • Terminated Z-0813-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004
    • Terminated Z-0812-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004
    • Terminated Z-0814-05 FDA Unclassified (pre-2012) initiated 12 Jul 2004

    Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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