SeeFactorCT3

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,…

Registry build 21.09.26

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.

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code OAS
Manufacturer City Province Registered as Device types
Changzhou Sifary Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 14
Fussen Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3
Yian Medical Technology (Haining) Co., Ltd. Jiaxing Zhejiang Specification developer 1
Changzhou Finno Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 1

Record

Regulatory record for SeeFactorCT3
Listed by Epica Medical Innovations LLC
FDA product code OAS
Device type X-Ray, Tomography, Computed, Dental
Device class Class 2
Regulation 21 CFR 892.1750
510(k) K190856
Record published 2021-06-30
Record revised 2024-10-30 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Distribution end date 2024-10-01

Catalogue Numbers

Catalogue numbers for SeeFactorCT3
Catalogue number Size Status
SeeFactorCT3 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rayscan RAY Co., Ltd., 52
Rayscan Studio RAY Co., Ltd., 21
Dental CT Scanner AXR Alliage S/A Indústrias Médico Odontológica 15
PaX-i3D Green Vatech Co., Ltd. 14
Orthopantomograph™ OP 3D Palodex Group OY 11
Sleeve for extraoral X-Ray devices Sirona Dental Systems Gmbh 11
SXR / Saevo Alliage S/A Indústrias Médico Odontológica 11
X-Mind trium DE Götzen SRL 10
Genoray Genoray Co., Ltd. 9
Rayscan α-Expert3D RAY Co., Ltd., 9
Orthophos SL Sirona Dental Systems Gmbh 9
Orthophos XG Sirona Dental Systems Gmbh 9

Showing 12 of 110. All products under X-Ray, Tomography, Computed, Dental

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer