The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a…
The Visica 2 Treatment System is a cryosurgical system consisting of a control unit that controls one single use disposable probe. The system utilizes a cryogen, liquid nitrogen, as a cooling agent and a resistance heater for thawing. The Visica 2 Console is a self contained, mobile unit featuring an easy to use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allow users to select treatment modes, times, and cycles.
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
Record
Regulatory record for Visica 2 | Listed by | Sanarus Medical, Inc., United States |
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| 510(k) | K062896 |
| Record published | 2016-09-06 |
| Record revised | 2022-04-08 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 500 to 1013 KiloPascal; Storage environment atmospheric pressure 700 to 1013 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature 15 to 30 °C; Handling environment temperature -20 to 55 °C; Handling environment humidity 10 to 90 % RH |
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.