The Fluoroscan InSight FD System is a mini C-Arm fluoroscopic imaging system designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited…
The Fluoroscan InSight FD System is a mini C-Arm fluoroscopic imaging system designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to, surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1).
Record
Regulatory record for Flourocsan InSight | Listed by | Hologic, Inc., United States |
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-23 |
| Record revised | 2024-04-19 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 20 to 80 % RH; Handling environment temperature 15 to 32 °C |
| UDI direct marking | Exempt |
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.