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# Zeta Surgical Cranial Navigation Device Cleared
- URL: https://www.fdaweb.com/zeta-surgical-cranial-navigation-device-cleared/
- Published: 2024-01-11T12:00:00.000Z
- Updated: 2026-09-14T14:20:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156122

FDA has cleared a Zeta Surgical 510(k) for its Zeta Cranial Navigation System. The mixed reality surgical navigation system is intended to provide neurosurgeons “GPS-like” guidance with millimetric accuracy in real time, according to the company. “Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement,” it says, adding that it can be deployed both inside and outside the operating room, which eliminates the need for general anesthesia and rigid skull immobilization.