Voyager Linux

FDA 510(k) K023975 · Z-Kat, Inc.

Substantially Equivalent

510(k) numberK023975

Submission

Device name
Voyager Linux
Applicant
Z-Kat, Inc.
Hollywood, FL, US
Received
December 2, 2002
Decision date
December 20, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Other 510(k)s with product code HAW

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K253663Zeta Navigation SystemHAW · Traditional Zeta Surgical, Inc.05/01/2026SE
K253379Stealth AXiS Cranial clinical applicationHAW · Traditional Medtronic Navigation, Inc.03/26/2026SE
K231897NeuroAlign softwareHAW · Traditional Medivis, Inc.10/21/2025SE
K251317SOLOPASS 2.0 SystemHAW · Traditional Intravent Medical Partners09/05/2025SE
K250893Ball Joint Guide Array (66295)HAW · Traditional Bayer Medical Care, Inc.09/04/2025SE
K250505Ez-FiducialsHAW · Traditional Phasor Health, LLC07/09/2025SE
K242575Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional Brain Navi Biotechnology Co., Ltd.05/23/2025SE
K241327Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional Claronav02/05/2025SE

More from Claronav

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Questions and answers

When was Voyager Linux cleared by the FDA?

Voyager Linux (K023975) received a 510(k) decision of Substantially Equivalent on December 20, 2002, 18 days after the submission was received.

What is the product code of K023975?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.