I.Z.I. Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “I.Z.I. Corp.” (first 1992, latest 2002), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
Most recent I.Z.I. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022074 | SPHERZ | HAW | 2002-08-13 | 48 |
| K014022 | MRI LINE MARKER | IYE | 2002-03-04 | 88 |
| K003736 | MRI LINE MARKER | JAK | 2001-01-18 | 45 |
| K994117 | MR ENHANCER | LNH | 2000-02-04 | 60 |
| K993742 | SUPER TISSUE | IYE | 2000-02-02 | 90 |
| K930752 | CT/MRI TOPOGRAPHIC MARKER | JAC | 1993-11-19 | 280 |
| K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS | KPQ | 1992-10-16 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named I.Z.I. Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under I.Z.I. Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under I.Z.I. Corp.?
FDA lists 7 510(k) clearances under the applicant name “I.Z.I. Corp.” (first 1992, latest 2002), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I.Z.I. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I.Z.I. Corp. is 88 days.
Which FDA product codes appear under I.Z.I. Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 2); HAW (Neurological Stereotaxic Instrument, 1); JAC (System, X-Ray, Film Marking, Radiographic, 1).
Next steps
- See all 7 I.Z.I. Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, I.Z.I. Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.