NeuroAlign software
FDA 510(k) K231897 · Medivis, Inc.
510(k) numberK231897
Submission
- Device name
- NeuroAlign software
- Applicant
- Medivis, Inc.
New York, NY, US - Received
- June 28, 2023
- Decision date
- October 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| 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 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | Brainlab AG | 01/28/2025SE |
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Questions and answers
When was NeuroAlign software cleared by the FDA?
NeuroAlign software (K231897) received a 510(k) decision of Substantially Equivalent on October 21, 2025, 846 days after the submission was received.
What is the product code of K231897?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.