Duns Number:079142095
Device Description: SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequenc SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Catalog Number
860005941605
Brand Name
SeeFactorCT3
Version/Model Number
SeeFactorCT3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K190856
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
7d12782d-336b-43e9-abf7-191661096a2e
Public Version Date
July 08, 2021
Public Version Number
1
DI Record Publish Date
June 30, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |