DEVICE: Corix 70 (00860010674406)
Device Identifier (DI) Information
Corix 70
Corix 70 Plus USV
In Commercial Distribution
Coramex, S.A.
Corix 70 Plus USV
In Commercial Distribution
Coramex, S.A.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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42066 | Stationary extraoral dental x-ray system, analogue |
A 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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EHD | Unit, X-Ray, Extraoral With Timer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K031802 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5e1c944f-ca9d-4c98-b513-17114ddb6813
January 18, 2024
1
January 10, 2024
January 18, 2024
1
January 10, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-847-459-3889
custromerservice@chicagox-ray.com
custromerservice@chicagox-ray.com