Voyager Trajectory Array Guide (V-TAG)
FDA 510(k) K191400 · Mri Interventions, Inc.
510(k) numberK191400
Submission
- Device name
- Voyager Trajectory Array Guide (V-TAG)
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- May 24, 2019
- Decision date
- June 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
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| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
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| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | 07/08/2015SE |
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Questions and answers
When was Voyager Trajectory Array Guide (V-TAG) cleared by the FDA?
Voyager Trajectory Array Guide (V-TAG) (K191400) received a 510(k) decision of Substantially Equivalent on June 21, 2019, 28 days after the submission was received.
What is the product code of K191400?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.