Midmark Extraoral Imaging System (Eois)
The Midmark Extraoral Imaging System produces dental X-ray images of the teeth, jaws and surrounding oral structures. Its basic configuration provides panoramic imaging, with cephalometric…
The Midmark Extraoral Imaging System produces dental X-ray images of the teeth, jaws and surrounding oral structures. Its basic configuration provides panoramic imaging, with cephalometric and cone-beam CT functions available in selected configurations or as upgrades.
For cone-beam CT, the system acquires two-dimensional X-ray projections from different angles. Reconstruction software converts these projections into a three-dimensional data set for volumetric and sectional examination.
Imaging Configurations
Small and medium CBCT configurations are available, with or without cephalometric imaging. The cephalometric option supports orthodontic examination and can perform carpal imaging for skeletal-age assessment when used with its carpal attachment. The installed imaging features determine which examinations the system can perform.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Yian Medical Technology (Haining) Co., Ltd. | Jiaxing | Zhejiang | Specification developer | 1 |
| Changzhou Finno Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Midmark Corporation, United States |
|---|---|
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K201667 |
| Record published | 2020-12-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-A1026 | In distribution | |
| 60-A0012 | In distribution | |
| 60-A2116 | In distribution | |
| 60-A0012 / 60-A0015 / 60-A1041 | In distribution | |
| 60-A0012 / 60-A1037 / 60-A1041 | In distribution | |
| 60-A0012 / 60-A0016 | In distribution | |
| 60-A0012 / 60-A0016 / 60-A1041 | In distribution | |
| 60-A1037 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rayscan | RAY Co., Ltd., | 52 |
| Rayscan Studio | RAY Co., Ltd., | 21 |
| Dental CT Scanner AXR | Alliage S/A Indústrias Médico Odontológica | 15 |
| PaX-i3D Green | Vatech Co., Ltd. | 14 |
| Orthopantomograph™ OP 3D | Palodex Group OY | 11 |
| Sleeve for extraoral X-Ray devices | Sirona Dental Systems Gmbh | 11 |
| SXR / Saevo | Alliage S/A Indústrias Médico Odontológica | 11 |
| X-Mind trium | DE Götzen SRL | 10 |
| Genoray | Genoray Co., Ltd. | 9 |
| Rayscan α-Expert3D | RAY Co., Ltd., | 9 |
| Orthophos SL | Sirona Dental Systems Gmbh | 9 |
| Orthophos XG | Sirona Dental Systems Gmbh | 9 |
Showing 12 of 110. All products under X-Ray, Tomography, Computed, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201667 | 2020-08-06 |
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.