| Primary Device ID | 86000594161101 |
| NIH Device Record Key | 5bbfde91-5df8-4de5-a265-56d66d6e9475 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeeFactor CT3 |
| Version Model Number | 9801101000 |
| Catalog Number | 86000594161101 |
| Company DUNS | 079142095 |
| Company Name | Epica Medical Innovations LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 86000594161101 [Primary] |
| OAS | X-Ray, Tomography, Computed, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-30 |
| Device Publish Date | 2021-03-22 |
| 00860005941605 - SeeFactorCT3 | 2021-07-08 SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose |
| 86000594161101 - SeeFactor CT3 | 2021-03-30SeeFactorCT3 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. |
| 86000594161101 - SeeFactor CT3 | 2021-03-30 SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose |