FDA.reportPublic FDA data

DRX Plus 4343 DETECTOR

Primary DI
60889971746146
Brand
DRX Plus 4343 DETECTOR
Company
CARESTREAM HEALTH, INC.
Model
DRX Plus 4343 DETECTOR
Catalog number
1746148
Device description
DRX Plus 4343 portable grid holder
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
IXJGrid, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXJGrid, RadiographicRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090318000CARESTREAM DRX-1 SYSTEMCarestream Health, Inc.2009-04-06MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971746146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997174614660889971746146

GMDN Terms#

Term, Definition table
TermDefinition
Stationary x-ray gridA component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.

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
04589744213199MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-12-19
04589744212628GRID FacileMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744212666MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213069MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213076MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
00884838125322Grid Landscape for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125339Grid Landscape for SkyPlate large Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125346Grid Portrait for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125353Grid Portrait for SkyPlate largePhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125360Grid Portrait for SkyPlate small Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125384Grid Portrait Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125391Grid Landscape Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125421X-Ray Grid 40/12/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125438X-Ray Grid 40/12/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125445X-Ray Grid 40/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125452X-Ray Grid 60/10/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125469X-Ray Grid 60/10/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125476X-Ray Grid 60/10/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125483X-Ray Grid 44/8/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125490X-Ray Grid 40/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125506X-Ray Grid 40/8/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125513X-Ray Grid 40/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125520X-Ray Grid 36/8/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125537X-Ray Grid 36/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125544X-Ray Grid 36/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125551X-Ray Grid 36/12/140 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125568X-Ray Grid 36/12/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125575X-Ray Grid 36/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125582X-Ray Grid 36/12/100 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125599X-Ray Grid 44/8/140 Philips Medical Systems DMC GmbHIXJ2025-06-19