Direx Systems Corp.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Direx Systems Corp.” (first 2003, latest 2012), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 74 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 | 1 | 237 |
| 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 | 9 | 9 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 7 | 7 |
| MUJ | System, Planning, Radiation Therapy Treatment | 3 | 3 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 2 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
Most recent Direx Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111947 | DUET MAGNA | LNS | 2012-03-01 | 237 |
| K102765 | PRONEX | IYE | 2010-12-07 | 74 |
| K072529 | TRACKPORT | IYE | 2007-10-26 | 49 |
| K071701 | TRACKLEAF-10 | IYE | 2007-07-23 | 32 |
| K063482 | CROSSPLAN / ACCUSOFT-XL V.4.04 | MUJ | 2006-12-14 | 27 |
| K062147 | INTEGRA SL | LNS | 2006-10-20 | 85 |
| K062032 | ACCUSOFT, ACCUSOFT XL | MUJ | 2006-10-05 | 79 |
| K061873 | VERT-X | OXO | 2006-08-18 | 46 |
| K061713 | MAGIS1;MAGIS2 | IYE | 2006-07-21 | 32 |
| K052212 | MIGUE | IYE | 2006-03-10 | 207 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Direx Systems 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 Direx Systems Corp.?
FDA lists 22 510(k) clearances under the applicant name “Direx Systems Corp.” (first 2003, latest 2012), across 5 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 Direx Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Direx Systems Corp. is 74 days.
Which FDA product codes appear under Direx Systems Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 9); LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 7); MUJ (System, Planning, Radiation Therapy Treatment, 3).
Next steps
- See all 22 Direx Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Direx Systems 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.