Gendex Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Gendex Corp.” (first 1984, latest 1995), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 3 | 3 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 3 | 3 |
| EAG | Cephalometer | 2 | 2 |
| EGN | Scissors, Surgical Tissue, Dental | 1 | 1 |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| IXJ | Grid, Radiographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Review panels
- Radiology (12)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Gendex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | GEX | 1995-06-29 | 23 |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | EGY | 1995-02-09 | 80 |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | EHD | 1994-02-18 | 121 |
| K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | EHD | 1993-09-29 | 357 |
| K931001 | ORALIX DC | EHD | 1993-09-14 | 200 |
| K932675 | GXP DENTAL X-RAY PROCESSOR | EGN | 1993-07-26 | 54 |
| K922165 | ATC725, ATC525, AND AP300 | IZO | 1992-07-27 | 80 |
| K920189 | GX-C CEPHALOMETER | EAG | 1992-04-28 | 104 |
| K894188 | GX-ELEVATOR | IZZ | 1989-10-03 | 109 |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | IZO | 1989-03-31 | 80 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-12.
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.
- Gendex Dental Systems (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gendex Corp.?
FDA lists 14 510(k) clearances under the applicant name “Gendex Corp.” (first 1984, latest 1995), across 9 product codes in 3 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 Gendex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gendex Corp. is 89 days.
Which FDA product codes appear under Gendex Corp.?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 3); IZO (Generator, High-Voltage, X-Ray, Diagnostic, 3); EAG (Cephalometer, 2).
Next steps
- See all 14 Gendex Corp. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Gendex 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.