Corix 70

Sistema diagnóstico de rayos X dental diseñado para fijación permanente en una ubicación con objeto de generar y controlar los haces de rayos X. Registra el patrón de absorción de los haces…

Registry build 21.09.26

Sistema diagnóstico de rayos X dental diseñado para fijación permanente en una ubicación con objeto de generar y controlar los haces de rayos X. Registra el patrón de absorción de los haces de rayos X utilizado para exámenes radiográficos dentales generales y rutinarios que implican el diagnóstico y tratamiento (p. ej., quirúrgico o intervencionista) de afecciones de las piezas dentales, mandíbula y cavidad bucal. El sensor se coloca fuera de la boca, con el propósito de visualizar toda el área de esta y mostrar las piezas dentales, tanto en la mandíbula superior como en la inferior. Los datos proceden de imágenes analógicas y que se digitalizan posteriormente o bien de imágenes digitales.

8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).

Chinese manufacturers registered for FDA product code EHD
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Changzhou Sifary Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 14
Guangzhou Ajax Medical Equipment Co Ltd Guangzhou Guangdong Manufacturer 13
Guilin Refine Medical Instrument Co., Ltd. Guilin Guangxi Contract manufacturer 7
iRay Imaging Technology (Haining) Limited Haining Zhejiang Contract manufacturer 6
Orich Medical Equipment (Tianjin) Co., Ltd. Tianjin Tianjin Manufacturer 5
Ningbo Runyes Medical Instrument Co., Ltd. Ningbo Zhejiang Contract manufacturer 4
Shenzhen Xpectvision Technology Co., Ltd. Shenzhen Guangdong Repacker / relabeller 4

Record

Regulatory record for Corix 70
Listed by Coramex, S.A., United States
FDA product code EHD
Device type Unit, X-Ray, Extraoral With Timer
Device class Class 2
Regulation 21 CFR 872.1800
510(k) K031802
Record published 2024-01-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries serial number

Catalogue Numbers

Catalogue numbers for Corix 70
Catalogue number Size Status
Corix 70 Plus USV In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Midmark Midmark Corporation 148
Midmark Preva IntraOral Dental X-ray System Midmark Corporation 136
Schick AE Sirona Dental, Inc. 53
Midmark Preva 2.0 IntraOral Dental X-ray System Midmark Corporation 46
Xios AE Sirona Dental, Inc. 38
X-Mind unity DE Götzen SRL 26
Midmark Vetpro IntraOral Dental X-ray System Midmark Corporation 26
x-mind dc DE Götzen SRL 17
Owandy-RX DC Owandy Radiology 16
Orthophos XG Sirona Dental Systems Gmbh 10
Schick Elite Sirona Dental, Inc. 10
Phot-X IIs Model 505 Takara Belmont Corporation 10

Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K031802 2003-07-21

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