Definition: Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
| Device Type ID | 5403 |
| Device Name | X-ray, Tomography, Computed, Dental |
| Physical State | X-ray Machine |
| Technical Method | Uses X-ray Scanning To Produce Computed Tomographic Images |
| Target Area | Mouth And Associated Stuctures |
| Regulation Description | Computed Tomography X-ray System. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.1750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5403 |
| Device | X-ray, Tomography, Computed, Dental |
| Product Code | OAS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Computed Tomography X-ray System. |
| CFR Regulation Number | 892.1750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARESTREAM DENTAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CEFLA S.C. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DE GOTZEN S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDLEN IMAGING LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENORAY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HDX WILL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMAGING SCIENCES INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PALODEX GROUP OY | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
PANORAMIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PLANMECA OY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PLANMED OY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PREXION CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
QR S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RAY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RAY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELESYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TROPHY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VATECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VILLA SISTEMI MEDICALI S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Villa Radiology Systems LLC | II | Nov-06-2015 |