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

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
05414904271124SE Suite2.0E5C342019-08-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410431957DRYPIX SmartFUJIFILM CORPORATIONLMC2024-06-07
04560141950474DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2022-07-06
60889976571002DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-08-02
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
04560141923126DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
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
60889971033840DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
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