FDA.reportPublic FDA data

CR Cassettes for Vita Systems

Primary DI
60889971033741
Brand
CR Cassettes for Vita Systems
Company
CARESTREAM HEALTH, INC.
Model
CR Cassettes for Vita Systems
Catalog number
1033745
Device description
CARESTREAM CR CASS W SCRN 8X10IN
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXACassette, radiographic film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945039000MCI OPTONIX CASSETTE OKAMOTO CASSETEMci Optonix, Inc.1994-11-22IXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971033741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088997103374160889971033741

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassette/storage phosphor screenA combination device for medical imaging applications that consists of a cassette used 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. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.

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
Lot or batch
true

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
00850077007293Huestis Medical Flexi-HolderHUESTIS MACHINE CORPORATIONIXA2025-03-05
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449413992KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415989KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
00810106410432dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410449dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410456dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410463dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410470dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410487dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410494dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410500dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410517dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410524dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410531dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410548dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410555dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410562dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410579dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410418dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
00810106410425dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
60889971033574DIRECTVIEW CR Long-Length Cassette with PQ ScreenCARESTREAM HEALTH, INC.IXA2021-06-06
00810050241236N/ADOMICO MED-DEVICE, LLCIXA2020-09-24
00810050240994NADOMICO MED-DEVICE, LLCIXA2020-09-24
60889978607334MIN-R 2 Cassette with MIN-R 2190 ScreenCARESTREAM HEALTH, INC.IXA2017-11-07
08809413810198Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810228Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810235Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810242Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01