The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY).…
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
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 Clear Guide Core | Listed by | Clear Guide Medical, United States |
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K171677 |
| Record published | 2022-10-06 |
| Record revised | 2022-10-25 (version 2) |
Specifications
Specifications | MRI safety | MR Conditional |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Storage environment humidity 10 to 80 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box |
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.