AccessGUDID - DEVICE: SeeFactorCT3 (00860005941605)

GUDID

Device Identifier (DI) Information

Brand Name: SeeFactorCT3
Version or Model: SeeFactorCT3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 860005941605
Company Name: Epica Medical Innovations LLC

Primary DI Number: 00860005941605
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079142095 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61019	Cone beam computed tomography system, head/neck	A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAS	X-Ray, Tomography, Computed, Dental
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190856	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d12782d-336b-43e9-abf7-191661096a2e
Public Version Date: October 30, 2024
Public Version Number: 2
DI Record Publish Date: June 30, 2021