FDA.report

CS 9300

Primary DI
60889978024186
Brand
CS 9300
Company
CARESTREAM HEALTH, INC.
Model
CS 9300
Catalog number
8024184
Device description
CS 9300 CBCT Unit Only
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OASX-ray, tomography, computed, dental

Product Code Classifications

CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889978024186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6088997802418660889978024186

GMDN Terms

TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RCT700Ray Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.OAS2025-11-24
08800003027002RCT700Ray Co., LtdOAS2025-08-25
08800003027019RCT700Ray Co., LtdOAS2025-08-25
08800003027033RCT700Ray Co., LtdOAS2025-08-25
08800003027040RCT700Ray Co., LtdOAS2025-08-25
08800003027057RCT800Ray Co., LtdOAS2025-08-25
08800003027095RAYSCAN α-3DRay Co., LtdOAS2025-08-25
06430035875191ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-07-15
08809244060243GenorayGENORAY CO., LTD.OAS2025-05-02
08800000996042T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800000996059T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800003027064RCT600Ray Co., LtdOAS2025-04-14
08800003027071RCT600Ray Co., LtdOAS2025-04-14
08809244060250GenorayGENORAY CO., LTD.OAS2025-03-24
08809244060281GenorayGENORAY CO., LTD.OAS2025-03-24
06430035875184ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-03-11