FDA.reportPublic FDA data

CS 8000C

Primary DI
60889975303703
Brand
CS 8000C
Company
CARESTREAM HEALTH, INC.
Model
CS 8000C
Catalog number
5303706
Device description
CS 8000C 230V 60HZ LEFT SIDE
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889975303703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997530370360889975303703

GMDN Terms#

Term, Definition table
TermDefinition
Stationary cephalometric x-ray system, digitalA stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. The sensor is placed outside the head. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25
60889971006240Vita LE CR SystemVita LE CR System10062462016-09-16
60889971014306CS 7600CS 760010143072016-09-16
60889971014313CS 7600CS 760010143152016-09-16
60889971023704CS 7600 SLOT PANELCS 7600 SLOT PANEL10237042016-09-16
60889971023711CS 7600 SLOT PANELCS 7600 SLOT PANEL10237122016-09-16
60889971024084Vita CR SystemVita CR System10240822016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
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
D7641000064561Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064571Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10