FDA.reportPublic FDA data

DRX - Ascend System

Primary DI
60889971739636
Brand
DRX - Ascend System
Company
CARESTREAM HEALTH, INC.
Model
DRX - Ascend System
Catalog number
1739630
Device description
Motorized Tilting Wall Stand (Left)
Published
2016-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KPRSystem, x-ray, stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971739636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997173963660889971739636

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, analogueAn assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image capture and display. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (mobile imaging facility). This system consists of modular configurations that can be upgraded by the addition of hardware/software components or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

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
06971576833702uDRShanghai United Imaging Healthcare Co., Ltd.KPR2026-03-08
06971576833719uDRShanghai United Imaging Healthcare Co., Ltd.KPR2026-03-08
00858340006523Del Medical, Inc.Del Medical, Inc.KPR2026-03-05
00858340006530Del Medical, Inc.Del Medical, Inc.KPR2026-03-05
08800098700040XVISION-525GEMSS Healthcare Co., Ltd.KPR2026-01-16
00817100020278KDR Floor Mount+ SystemKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2026-01-08
00817100021282KDR Floor Mount SystemKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2026-01-08
00195278913814DefiniumGE Hualun Medical Systems Co., LtdKPR2025-09-05
04056869962214YSIO X.preeSiemens Healthcare GmbHKPR2025-08-11
00817100021268KDR DDR Primary U Arm KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.KPR2025-07-30
03663999000405EOSedgeEOS IMAGINGKPR2025-05-14
B619X20Q9XPERT20KubtecKPR2025-03-26
08800018421505EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421604EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421703EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421802EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018421901EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422007EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422106EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422205EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422304EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018422403EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425503EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425602EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425701EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425800EXSYS DEXiDRTECH CorporationKPR2025-03-25
08800018425909EXSYS DEXiDRTECH CorporationKPR2025-03-25
00860001404753MasteRadMedicatech Usa, Inc.KPR2024-12-20
08806095799636NASamsung Electronics Co., Ltd.KPR2024-10-18
08806095799643NASamsung Electronics Co., Ltd.KPR2024-10-18