Xre Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Xre Corp.” (first 1977, latest 1997), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 10 | 10 |
| IXR | Table, Radiographic, Tilting | 3 | 3 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| GDC | Table, Operating-Room, Electrical | 1 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 1 |
| IZW | Collimator, Automatic, Radiographic | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (18)
- General and Plastic Surgery (1)
Most recent Xre Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | JAA | 1997-12-29 | 89 |
| K961193 | FULL FRAME ZOOM SYSTEM | JAA | 1996-06-17 | 88 |
| K960998 | XRE COLLIMATOR | IZW | 1996-04-03 | 22 |
| K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM | IZI | 1995-02-27 | 112 |
| K936002 | CINEMAC QAS | IZI | 1994-09-09 | 268 |
| K933460 | DVFX, MODEL M256 | IZI | 1994-04-07 | 265 |
| K924828 | BI-N | IZI | 1992-12-17 | 80 |
| K923654 | POLY DIAGNOST CDX | IZI | 1992-11-20 | 122 |
| K913685 | UNICATH EP. | IZI | 1991-11-07 | 80 |
| K912416 | ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM | IZI | 1991-08-28 | 89 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Xre 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Xre Corp.?
FDA lists 20 510(k) clearances under the applicant name “Xre Corp.” (first 1977, latest 1997), across 8 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 Xre Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xre Corp. is 80 days.
Which FDA product codes appear under Xre Corp.?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 10); IXR (Table, Radiographic, Tilting, 3); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 2).
Next steps
- See all 20 Xre Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZI, Xre 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.