Device |
x-ray, tomography, computed, dental |
Definition |
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth. |
Physical State |
X-ray machine |
Technical Method |
Uses x-ray scanning to produce computed tomographic images |
Target Area |
Mouth and associated stuctures |
Regulation Medical Specialty |
Radiology |
Review Panel |
Radiology |
Product Code | OAS |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
Division of Radiological Health
(DRH)
|
Submission Type |
510(k)
|
Regulation Number |
892.1750
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |