Z-Kat, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Z-Kat, Inc. makes
Z-Kat, Inc. manufactures medical imaging devices for fluoroscopy, including the Z-BOX, a system for real-time X-ray imaging, and the FLUOROLAB PLUS and its modifications, designed for laboratory fluoroscopy applications. The company also produces the VOYAGER LINUX, a software platform for medical imaging, and the Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI, a fluoroscopic guidance tool for procedural interventions.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in the United States, where they are subject to FDA oversight.
Catalogue
Z-Box Ref K030764
510(k) 510(k)Fluorolab Plus Ref K002893
510(k) 510(k)Modification To Flourolab Plus Ref K013025
510(k) 510(k)Voyager Linux Ref K023975
510(k) 510(k)Z Kat Flurotactic Guidance System Mki Ref K984298
510(k) 510(k)
Frequently asked questions
How many devices does Z-Kat, Inc. have in the registry?
The registry currently lists 5 devices for Z-Kat, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Z-Kat, Inc.'s devices?
Among its 5 most recently registered devices, Z-Kat, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Z-Kat, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Z-Kat, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Z-Kat, Inc. in the registry?
The most recently registered devices listed for Z-Kat, Inc. include Z-BOX, FLUOROLAB PLUS, MODIFICATION TO FLOUROLAB PLUS and VOYAGER LINUX.