FDA.reportPublic FDA data

DRYSTAR AXYS XL

Primary DI
05414904200520
Brand
DRYSTAR AXYS XL
Company
AGFA
Model
5367/400
Catalog number
55SM3
Device description
DRYSTAR AXYS XL
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMCCamera, multi format, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072680000DRYSTAR AXYS, MODEL EYZ4EAgfa Healthcare Corporation2007-10-25LMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414904200520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904200520054149042005205414904200520

GMDN Terms#

Term, Definition table
TermDefinition
Video printerA device designed for making printed (hard) copies of medical video images. These can be taken by digital cameras or image processing results of different imaging devices or systems [e.g., ultrasound (US), magnetic resonance imaging (MRI), computed tomography (CT) or radiographic images].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)777-2432salesinfo@agfa.com

Regulatory Flags#

DUNS number
374444883
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414904027158CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 10X12EJY1G2016-09-01
05414904027202CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X43EJYU32016-09-01
05414904027219CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X35EJYV52016-09-01
05414904027226CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 24X30EJYW72016-09-01
05414904027363CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 18X24EJYXA2016-09-01
05414904027509CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 15X30EJYYC2016-09-01
05414904027516CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 8X10EJYZE2016-09-01
05414904027943CR MD4.0T PLATECR MD4.0T PLATE 35X43E4UWL2016-09-01
05414904027967CR MD4.0T PLATECR MD4.0T PLATE 24X30E4UZR2016-09-01
05414904027998CR MD4.0T PLATECR MD4.0T PLATE 18X24E4VCK2016-09-01
05414904028001CR MD4.0T PLATECR MD4.0T PLATE 15X30E4VEO2016-09-01
05414904043257CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 15X30E5PU32016-09-01
05414904043264CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 18X24E5PT12016-09-01
05414904043271CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 24X30E5PSY2016-09-01
05414904043288CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X35E5PRW2016-09-01
05414904043295CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X43E5PNO2016-09-01
05414904043301CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X35E5POQ2016-09-01
05414904043318CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X43E5PMM2016-09-01
05414904044100CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 14X515O6MS2016-09-01
05414904092538CR MD1.0 GENERAL PLATECR MD1.0 GENERAL PLATE 35X435R3HW2016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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60889976559352DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-04-28
04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141932494DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141945630DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141945647DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141921641DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141922686DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141923119DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
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04547410080520FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080551FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080773FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080797FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142433FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142457FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222494FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222548FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222555FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222562FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222579FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410265965FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410265989FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
60889971020178DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
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60889971046024DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055378DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055392DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16