MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided…
MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Maxio | Listed by | Perfint Healthcare Pvt, Ltd., United States |
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| 510(k) | K132108 |
| Record published | 2018-05-04 |
| Record revised | 2026-03-19 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | 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.