FDA.reportPublic FDA data

CR HD5.0 AEC CASSETTE

Primary DI
05414904044155
Brand
CR HD5.0 AEC CASSETTE
Company
AGFA
Model
CR HD5.0 AEC CASSETTE 35X43
Catalog number
5PCQV
Device description
CR HD5.0 AEC CASSETTE 35X43CM
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
05414904044155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904044155054149040441555414904044155

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassetteA device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter
Width43Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
374444883
Device count
1
Lot or batch
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