Smit Rontgen
NetherlandsFDA applicant, unverified
- Devices
- 1
What Smit Rontgen makes
Smit Rontgen manufactures fibre interspaced X-ray grids, which are used to reduce scatter radiation in medical imaging for improved image clarity.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Fibre Interspaced X-Ray Grid Ref K963893
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smit Rontgen have in the registry?
The registry currently lists 1 device for Smit Rontgen. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smit Rontgen's devices?
Among its 1 most recently registered device, Smit Rontgen has devices listed in FDA 510(k) (1 device).
What risk classes do Smit Rontgen's devices fall under?
Among its 1 most recently registered device, the classes recorded for Smit Rontgen's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Smit Rontgen in the registry?
The most recently registered devices listed for Smit Rontgen include FIBRE INTERSPACED X-RAY GRID.