FDA.reportPublic FDA data

CS 7400

Primary DI
60889971337221
Brand
CS 7400
Company
CARESTREAM HEALTH, INC.
Model
CS 7400
Catalog number
1337229
Device description
CR SEMI-FIN PLATE PAN V2 15X30CM
Published
2016-09-16
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

Product Codes#

Code, Name table
CodeName
MUHSystem,x-ray,extraoral source,digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971337221PackageGS120In Commercial Distribution
40889971337227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997133722160889971337221
4088997133722740889971337227

GMDN Terms#

Term, Definition table
TermDefinition
Dental computed radiography digital imaging scannerA device/device assembly designed to be used with an analogue dental 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 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; this device is dedicated to dental use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793169512
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25
60889971006240Vita LE CR SystemVita LE CR System10062462016-09-16
60889971014306CS 7600CS 760010143072016-09-16
60889971014313CS 7600CS 760010143152016-09-16
60889971023704CS 7600 SLOT PANELCS 7600 SLOT PANEL10237042016-09-16
60889971023711CS 7600 SLOT PANELCS 7600 SLOT PANEL10237122016-09-16
60889971024084Vita CR SystemVita CR System10240822016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01