The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition…
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Extension Cable localizer 3) FootSwitch 4) Double Instrument support 5) PC mouse 6) Service Keyboard 7)DVI monitor cable 8) VGA monitor cable 9)Monitor cable control 10) HDMI monitor cable 11) Composite video Cable 12) Power Cable (US)
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Fiagon Navigation Unit | Listed by | Fiagon GMBH, Germany |
| FDA product code | PGW |
| Device type | Ear, Nose, And Throat Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| Record published | 2016-08-05 |
| Record revised | 2024-09-06 (version 7) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Protected aginst dust and moisture; Handling environment temperature 15 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Sizes | Height 135 mm; width 315 mm; weight 11.7 kg; length 365 mm |
| Distribution end date | 2025-01-23 |
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.