Epica Medical Innovations LLC

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Tomography, Computed (JAK) (2) X-Ray, Tomography, Computed, Dental (OAS) (2)

Premarket Exempt

Clear

SeeFactorCT3 - 00860005941605 Catalog Number : 860005941605

Device Description : SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquir 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.

Device Class : 2

Duns Number: 079142095

Premarket Exempt : No

Product Code : OAS, JAK

Prescription Use : Yes

Device Count : 1

SeeFactor CT3 - 86000594161101 Catalog Number : 86000594161101

Device Description : SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquir SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head includingthe 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 indiagnostic 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.