| Device Type ID | 5257 |
| Device Name | Unit, X-ray, Extraoral With Timer |
| Regulation Description | Extraoral Source X-ray System. |
| Regulation Medical Specialty | Dental |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.1800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EHD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 5257 |
| Device | Unit, X-ray, Extraoral With Timer |
| Product Code | EHD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extraoral Source X-ray System. |
| CFR Regulation Number | 872.1800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEFLA S.C. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DE GOTZEN S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTERPRISE INTERNATIONAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIGIMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENORAY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HDX WILL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTEM IMPLANT CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SKANRAY TECHNOLOGIES PVT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAKARA BELMONT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Battery Problem | 83 |
Migration Or Expulsion Of Device | 37 |
Device Operational Issue | 12 |
Unintended Movement | 7 |
Detachment Of Device Component | 6 |
Maintenance Does Not Comply To Manufacturers Recommendations | 6 |
Insufficient Information | 5 |
Break | 3 |
Mechanical Problem | 3 |
Component Falling | 3 |
Installation-Related Problem | 3 |
Melted | 3 |
Device Dislodged Or Dislocated | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Handling Problem | 2 |
Material Fragmentation | 2 |
Device Maintenance Issue | 2 |
Thermal Decomposition Of Device | 2 |
Overheating Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
Temperature Problem | 1 |
Radiation Output Problem | 1 |
Device Emits Odor | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Misassembly By Users | 1 |
Insufficient Heating | 1 |
Inadequate Service | 1 |
Device Displays Incorrect Message | 1 |
Fire | 1 |
Device Operates Differently Than Expected | 1 |
Improper Device Output | 1 |
Power Problem | 1 |
Radiation Overexposure | 1 |
Handpiece | 1 |
Unstable | 1 |
| Total Device Problems | 202 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aribex Inc | II | Sep-02-2016 |
| 2 | Carestream Health Inc. | II | Mar-04-2014 |
| 3 | Gendex Corp | II | Oct-02-2014 |
| 4 | Instrumentarium Dental, PaloDEx Group Oy | II | Feb-25-2014 |
| 5 | Panoramic Rental Corp. | II | Jan-09-2018 |
| 6 | Panoramic Rental Corp. | II | Oct-04-2016 |
| 7 | Panoramic Rental Corp. | II | Sep-01-2015 |