Gendex Expert DC™ Intraoral X-Ray System
55 Inch Reach
8manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
Record
| Listed by | Gendex Corp., United States |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K992610 |
| Record published | 2016-09-27 |
| Record revised | 2022-01-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0.822.5212 | In distribution | |
| 1.006.2581 | In distribution | |
| 0.822.5214 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 148 |
| Midmark Preva IntraOral Dental X-ray System | Midmark Corporation | 136 |
| Schick AE | Sirona Dental, Inc. | 53 |
| Midmark Preva 2.0 IntraOral Dental X-ray System | Midmark Corporation | 46 |
| Xios AE | Sirona Dental, Inc. | 38 |
| X-Mind unity | DE Götzen SRL | 26 |
| Midmark Vetpro IntraOral Dental X-ray System | Midmark Corporation | 26 |
| x-mind dc | DE Götzen SRL | 17 |
| Owandy-RX DC | Owandy Radiology | 16 |
| Orthophos XG | Sirona Dental Systems Gmbh | 10 |
| Schick Elite | Sirona Dental, Inc. | 10 |
| Phot-X IIs Model 505 | Takara Belmont Corporation | 10 |
Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K935046 | 1994-02-18 |
| K925094 | 1993-09-29 |
| K931001 | 1993-09-14 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Gendex Corp. | 510(k) number | 2014-08-12 | Class II | Nonconforming Material/Component | 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 i | 651 | 2017-03-24 |
| Gendex Dental Systems | 510(k) number | 2011-12-29 | Not classified | Nonconforming Material/Component | Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly. | 52 | 2012-06-01 |
| Gendex Dental Systems | 510(k) number | 2010-12-20 | Not classified | Nonconforming Material/Component | The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate. | 34 wall plates | 2012-08-14 |
| Gendex Dental Systems | 510(k) number | 2010-12-17 | Not classified | Component design/selection | 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. | 5 units | 2011-02-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.