FDA.reportPublic FDA data

DX-M

Primary DI
05414904050385
Brand
DX-M
Company
AGFA
Model
5170/200
Catalog number
E4YW2
Device description
DX-M DIGITIZER
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
MUEFull field digital,system,x-ray,mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111324000CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERAgfa Healthcare N.V.2011-12-22MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414904050385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904050385054149040503855414904050385

GMDN Terms#

Term, Definition table
TermDefinition
Computed radiography digital imaging scannerA device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
08809244065088GenorayGENORAY CO., LTD.MUE2025-07-24
15420045517851Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517882Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517899Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517905Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517912Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517929Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517936Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517943Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517950Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517967Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517974Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517981Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517998Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
08809394330357VIVIX-M 1824SVIEWORKS CO., LTD.MUE2025-07-15
08809394330364VIVIX-M 2430SVIEWORKS CO., LTD.MUE2025-07-15
088000186022562430TCARayence Co., Ltd.MUE2025-04-08
00195278914026Senographe PristinaGE MEDICAL SYSTEMSMUE2025-01-09
10195278901764Not ApplicableGE MEDICAL SYSTEMSMUE2025-01-09
00195278866899not applicableGE MEDICAL SYSTEMSMUE2024-06-07
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278719812not applicableGE MEDICAL SYSTEMSMUE2024-04-11
00195278795724not applicableGE MEDICAL SYSTEMSMUE2024-01-22
00195278711229not applicableGE MEDICAL SYSTEMSMUE2023-09-14
00195278655141not applicableGE MEDICAL SYSTEMSMUE2023-07-28
00195278661999Senographe PristinaGE MEDICAL SYSTEMSMUE2023-07-28