Trex Medical Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Trex Medical Corp.” (first 1998, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| IZH | System, X-Ray, Mammographic | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| IZW | Collimator, Automatic, Radiographic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (6)
Most recent Trex Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992229 | MXU-125 OR TMX-125 | IZL | 1999-08-06 | 35 |
| K984092 | PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 | IZH | 1999-02-05 | 81 |
| K984091 | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 | IZH | 1999-02-05 | 81 |
| K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER | IZW | 1998-12-30 | 20 |
| K982427 | TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C | OWB | 1998-09-23 | 72 |
| K982120 | DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) | LLZ | 1998-09-10 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Trex Medical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Trex Enterprises Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trex Medical Corp.?
FDA lists 6 510(k) clearances under the applicant name “Trex Medical Corp.” (first 1998, latest 1999), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trex Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trex Medical Corp. is 76 days.
Which FDA product codes appear under Trex Medical Corp.?
The most frequent FDA product codes under this applicant name are IZH (System, X-Ray, Mammographic, 2); IZL (System, X-Ray, Mobile, 1); IZW (Collimator, Automatic, Radiographic, 1).
Next steps
- See all 6 Trex Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZH, Trex Medical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.