Corix 70

Primary DI
00860010674406
Brand
Corix 70
Company
Coramex, S.A.
Model
Corix 70 Plus USV
Device description
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.
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031802000CORIX 70 PLUS-USVCoramex, S.A.2003-07-21EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010674406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010674406008600106744068600106744060860010674406

GMDN Terms#

Term, Definition table
TermDefinition
Stationary extraoral dental x-ray system, analogueA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The image is from film or phosphor plate.

Contacts#

Phone, Email table
PhoneEmail
+1-847-459-3889custromerservice@chicagox-ray.com

Regulatory Flags#

DUNS number
821544657
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
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08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
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08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10