FDA.reportPublic FDA data

CS 8100SC

Primary DI
60889975314563
Brand
CS 8100SC
Company
CARESTREAM HEALTH, INC.
Model
CS 8100SC
Catalog number
5314562
Device description
SC UPGRADE FOR CS 8100
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MUHSystem,x-ray,extraoral source,digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889975314563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997531456360889975314563

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
60889978625925Carestream DRX-1 SystemCarestream DRX-1 System86259232023-07-21
60889978624768DRX-Compass X-ray SystemDRX-Compass X-ray System86247692023-06-28
00889978626487D-SpeedD-Speed86264832023-06-26
60889978818891Ultra-speedUltra-speed88188902023-06-26
60889976554104CARESTREAM DR Long Length Imaging StandCARESTREAM DR Long Length Imaging Stand65541092023-06-26
60889975950600Focus HD 35 DetectorFocus HD 35 DetectorAL47122023-06-24
60889975950617Focus HD 43 DetectorFocus HD 43 DetectorAL47132023-06-24
60889978626007DRX-Rise Mobile X-ray SystemDRX-Rise Mobile X-ray System86260042023-06-22
60889976701171CARESTREAM Image SuiteCARESTREAM Image Suite67011712022-02-25
60889971051264D-SpeedD-Speed10512672022-01-11
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889978624195DRX-Compass X-ray SystemDRX-Compass X-ray System86241992022-01-11
60889975950532DRX Plus 3543 DetectorDRX Plus 3543 DetectorAL67502021-09-04
60889975950549DRX Plus 3543C DetectorDRX Plus 3543C DetectorAL67552021-09-04
60889975950556DRX Plus 4343 DETECTORDRX Plus 4343 DETECTORAL67592021-09-04
60889975950563DRX Plus 4343C DETECTORDRX Plus 4343C DETECTORAL67642021-09-04
60889975950570Lux 35 DetectorLux 35 DetectorAK72942021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLMUH2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
06970569090856Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
06970569090863Digital Intraoral X-ray Imaging SystemiRay GroupMUH2025-08-29
D178XR3800Flight Dental SystemsFlight Dental Systems USA Inc.MUH2025-08-29
08800003027088RAYSCAN α-PRay Co., LtdMUH2025-08-25
03760262650814Owandy RadiologyOWANDY RADIOLOGYMUH2025-05-15
D804W13000050U-SENSE HDDE GÖTZEN SRLMUH2025-05-15
08809244060199GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060229GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060236GenorayGENORAY CO., LTD.MUH2025-05-02
00304040190623Henry ScheinHENRY SCHEIN, INC.MUH2025-03-05
06941877815196EighteethChangzhou Sifary Medical Technology Co., Ltd.MUH2025-01-21
08033837936817myrayCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936848NewTomCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08033837936855CastelliniCEFLA SOCIETA' COOPERATIVAMUH2024-12-31
08800016401950VistaPano S 2.0VATECH CO., LTD.MUH2024-12-13
08800016401967VistaPano S Ceph 2.0VATECH CO., LTD.MUH2024-12-13
D9021050013MISTER X RAYDental Savings Club IncMUH2024-12-12
03760262651606I-MAXOWANDY RADIOLOGYMUH2024-11-11
D804W1200001FL0X-MIND primeDE GÖTZEN SRLMUH2024-11-11