Fluoro Scan Imaging Systems, Inc.
Country not established
- Devices
- 1
What Fluoro Scan Imaging Systems, Inc. makes
Fluoro Scan Imaging Systems, Inc. manufactures fluoroscopic imaging systems, including the FLUOROSCAN PROFILE (Model TCA 4 PLUS and TCA 4R PLUS) and its IQ variant. These devices are designed for real-time X-ray imaging, primarily used in medical procedures requiring intraoperative visualization, such as orthopedic surgeries or interventional radiology.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The systems are listed in the FDA’s 510(k) database, reflecting their regulatory authorization in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fluoro Scan Imaging Systems, Inc. have in the registry?
The registry currently lists 1 device for Fluoro Scan Imaging Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fluoro Scan Imaging Systems, Inc.'s devices?
Among its 1 most recently registered device, Fluoro Scan Imaging Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Fluoro Scan Imaging Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Fluoro Scan Imaging Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fluoro Scan Imaging Systems, Inc. in the registry?
The most recently registered devices listed for Fluoro Scan Imaging Systems, Inc. include FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS.