The Zeta Navigation System is a stereotactic, image-guided planning and intraoperative guidance system enabling computer-assisted cranial surgical procedures. The system assists surgeons in…
The Zeta Navigation System is a stereotactic, image-guided planning and intraoperative guidance system enabling computer-assisted cranial surgical procedures. The system assists surgeons in the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans. A core feature of the Zeta Navigation System is that it can provide surgical navigation without the need for rigid head immobilization, body-mounted frames, or fiducials, instead using its underlying RealTrack algorithm for accurate, real-time tracking of head movement using only the patient’s native anatomical features. This enables the ZETA system to be deployed in less acute surgical settings such as interventional procedure suites, with minimal setup time or workflow interruption, and relying only on non-procedure-specific 3D imaging. The Zeta Navigation System consists of a single cart, a software user interface, and a set of compatible navigated instruments, sterile equipment covers, and surgical drapes.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Zeta Navigation System | Listed by | Zeta Surgical Inc., United States |
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K242351 |
| Record published | 2026-06-02 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.