I.Z.I. Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What I.Z.I. Corp. makes
I.Z.I. Corp. manufactures medical devices for radiation therapy and imaging, including disposable skin markers for radiation treatment planning, topographic markers for CT and MRI scans, and MRI line markers for precise anatomical alignment. Their portfolio also includes an MRI enhancer and a spherical reference marker (SPHERZ) for imaging applications, as well as a tissue-specific product called SUPER TISSUE.
The company’s devices are regulated under FDA’s 510(k) clearance process, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Super Tissue Ref K993742
510(k) 510(k)E.Z. Port(Tm) Radiation Therapy Skin Markers Ref K922287
510(k) 510(k)Ct/Mri Topographic Marker Ref K930752
510(k) 510(k)Mri Line Marker Ref K014022
510(k) 510(k)Mr Enhancer Ref K994117
510(k) 510(k)Mri Line Marker Ref K003736
510(k) 510(k)Spherz Ref K022074
510(k) 510(k)
Frequently asked questions
How many devices does I.Z.I. Corp. have in the registry?
The registry currently lists 7 devices for I.Z.I. Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list I.Z.I. Corp.'s devices?
Among its 7 most recently registered devices, I.Z.I. Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do I.Z.I. Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for I.Z.I. Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from I.Z.I. Corp. in the registry?
The most recently registered devices listed for I.Z.I. Corp. include SUPER TISSUE, E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS, CT/MRI TOPOGRAPHIC MARKER and MRI LINE MARKER.