Gendex Corp.
Des Plaines, IL, US
Gendex Corp. appears in FDA device records in Des Plaines, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Gendex Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Gendex Dental Systems510(k), recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Gendex Corp. between 1984 and 2006. The busiest year on record is 1993, with 3. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 2 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060178 | VIX WIN PRO | MUH | Substantially Equivalent | |
| K050255 | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 | EHD | Substantially Equivalent | |
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | GEX | Substantially Equivalent | |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | EGY | Substantially Equivalent | |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | EHD | Substantially Equivalent | |
| K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | EHD | Substantially Equivalent | |
| K931001 | ORALIX DC | EHD | Substantially Equivalent | |
| K932675 | GXP DENTAL X-RAY PROCESSOR | EGN | Substantially Equivalent | |
| K922165 | ATC725, ATC525, AND AP300 | IZO | Substantially Equivalent | |
| K920189 | GX-C CEPHALOMETER | EAG | Substantially Equivalent | |
| K894188 | GX-ELEVATOR | IZZ | Substantially Equivalent | |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | IZO | Substantially Equivalent | |
| K873982 | GX-MOBILE X-RAY UNIT | IZL | Substantially Equivalent | |
| K854499 | GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR | IZO | Substantially Equivalent | |
| K854459 | TBX MEDICAL X-RAY TABLE | IXJ | Substantially Equivalent | |
| K842463 | GX CEPH | EAG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EAGCephalometer
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXJGrid, Radiographic
- GEXPowered Laser Surgical Instrument
- EGYProcessor, Radiographic-Film, Automatic, Dental
- EGNScissors, Surgical Tissue, Dental
- MUHSystem, X-Ray, Extraoral Source, Digital
- IZLSystem, X-Ray, Mobile
- IZZTable, Radiographic, Non-Tilting, Powered
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0009-2015 | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm. | Class II | Terminated | |
| Z-1358-2012 | Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography | Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly. | Terminated | ||
| Z-2041-2011 | Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area. | There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou | Terminated | ||
| Z-2040-2011 | Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area. | There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou | Terminated | ||
| Z-1373-2011 | Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area. | The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units manufactured between 12/4/09 and 5/16/10 had functioning AEC buttons, but their manuals stated they were disabled. Units intended for International distribution bet | Terminated | ||
| Z-1559-2011 | Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs. | The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate. | Terminated | ||
| Z-1248-2011 | Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA | The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient. | Terminated | ||
| Z-1548-2009 | Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. | There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain