Instatrak 3000 System with Fluorotrak Module, Model IT3000

510(k) K994270

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK994270	Date9 Mar 2000Cleared	StatusActive

3 recalls · FDA

- 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-2136-2012 FDA Class I initiated 2 Apr 2007
The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
- Terminated Z-0709-06 FDA Unclassified (pre-2012) initiated 6 Feb 2006
Small retaining pin may detach and fall into the surgical field during stereotactic surgery.

1 jurisdiction

United States — FDA 510(k) Active

510(k)