The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The RegistrationPointert Cranial is…
The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH. The instrument is accessories to the Fiagon Navigation system. The Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
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 RegistrationPointer Cranial | Listed by | Fiagon GMBH, Germany |
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K151156 |
| Record published | 2016-08-10 |
| Record revised | 2024-09-06 (version 8) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 15 to 35 °C |
| Distribution end date | 2024-09-05 |
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.