FDA.reportPublic FDA data

CR 10-X

Primary DI
05414904092514
Brand
CR 10-X
Company
AGFA
Model
5151/100
Catalog number
5R3EQ
Device description
CR 10-X 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid state x-ray imager (flat panel/digital imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414904092514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904092514054149040925145414904092514

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414904271124SE Suite2.0E5C342019-08-05
05414904208168NX 3.0V3.0E3M812023-07-18
05414904233320NX 4.0V4.0XCU8O2023-07-18
05414904281321DR 4005520/150MBFTK2023-03-23
05414904225066Mamoray HDR-C PlusMAMORAY HDR-C PLUS 18x24EMG8K2022-11-16
05414904231678Dentus M2 ComfortDENTUS M2 COMFORT 3x4cm34HMO2022-11-16
05414904231692Dentus M2 ComfortDENTUS M2 COMFORT 3x4cm34HLM2022-11-16
05414904231531Dentus Ortholux RegisterDentus Ortholux Register 15X30EEG5O2022-11-04
05414904224786DM2 BDM 2 B 35x43EP1ND2022-11-04
05414904221464G PlusG Plus 35x92EZQG72022-11-04
05414904225363B Plus - Full BlueB PLUS-FULL BLUE 35x92EKYB82022-11-04
05414904231579Dentus E-SpeedDENTUS E-SPEED 3x4E2O5U2022-11-04
05414904231654Dentus M2 ComfortDENTUS M2 COMFORT 2x3cm34HNQ2022-11-04
05414904236949Dentus M2 ComfortDENTUS M2 Comfort 2x3cm34HOS2022-11-04
05414904231630Dentus OrtholuxDENTUS ORTHOLUX 13X3139N5L2022-10-31
05414904231593Dentus OrtholuxDENTUS ORTHOLUX 20X2539N8R2022-10-31
05414904231616Dentus OrtholuxDENTUS ORTHOLUX 15X3039N6N2022-10-31
05414904042830DRYSTAR DT 2 MAMMODRYSTAR DT 2 MAMMO 25X30ERE6E2022-10-31
05414904042816DRYSTAR DT 2 MAMMODRYSTAR DT 2 MAMMO 20x25ERE5C2022-10-31
05414904225486DRYSTAR DT 2 BDRYSTAR DT 2 B 25 x 30EKMEY2022-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800018408209EXPD 4343SDRTECH CorporationMQB2026-03-17
08800018408308EXPD 4343DDRTECH CorporationMQB2026-03-17
08800018408407EXPD 3643DDRTECH CorporationMQB2026-03-17
04549292223774CANON INC.CANON INC.MQB2026-02-06
00854344007795Varex Digital Imaging Software, Nexus DR, v4.19VAREX IMAGING CORPORATIONMQB2026-01-16
04719879300130YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300147YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300154YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300161YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
08800069500105BONX805, DIONE-X80 Portable X-ray Imaging Devicebontech IncMQB2025-12-03
00854344007771Varex Digital Imaging Software, Nexus DR, v4.18VAREX IMAGING CORPORATIONMQB2025-11-13
08800069500013BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500020BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500037BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500044BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500051BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500068BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
04547410484786FDR D-EVO III G35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484793FDR D-EVO III G43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484809FDR D-EVO III C35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484816FDR D-EVO III C43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484823FDR D-EVO III C25iFUJIFILM CORPORATIONMQB2025-08-29
04547410511673FDR D-EVO III G80iFUJIFILM CORPORATIONMQB2025-08-29
04547410515176DR-ID 1200MCFUJIFILM CORPORATIONMQB2025-08-29
08800018430002EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430101EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430200EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430309EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430408EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430507EXPD-N seriesDRTECH CorporationMQB2025-06-13