FDA.reportPublic FDA data

Radiographic Film Cassette

Primary DI
08809413810228
Brand
Radiographic Film Cassette
Company
JPI HEALTHCARE. CO., LTD.
Model
AFAB-W TYPE
Device description
Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IXACassette, Radiographic Film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809413810228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809413810228088094138102288809413810228

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette, manualA device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.

Regulatory Flags#

DUNS number
687797852
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809413811096ExamVue ApexEVA 10W2026-05-14
08809413811126ExamVue ApexEVA 14W2026-05-14
08809413811133ExamVue ApexEVA 17W2026-05-14
08809413810525Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:1)Grid-10002020-11-11
08809413810679ExamVue ExamVue Duo2023-06-15
08809413810532Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:2)Grid-10002020-11-11
08809413810549Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:3)Grid-10002020-11-11
08809413810556Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:4)Grid-10002020-11-11
08809413810563Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:5)Grid-10002020-11-11
08809413810570Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:6)Grid-10002020-11-11
08809413810587Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:7)Grid-10002020-11-11
08809413810594Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:8)Grid-10002020-11-11
08809413810600Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:9)Grid-10002020-11-11
08809413810617Box for radiographic Grid-1000(G5(outside620mmx140mmx590mm),packing quantity:10)Grid-10002020-11-11
08809413810495Box for radiographic Grid-1000(P-5(outside 1440mmx190mmx160mm))Grid-10002020-11-03
08809413810501Box for radiographic Grid-1000(P-10(outside 1440mmx340mmx590mm))Grid-10002020-11-03
08809413810518Box for radiographic Grid-1000(P-15 (outside 1440mmx890mmx590mm))Grid-10002020-11-03
08809413810471Box for ExamVue PACS(outside 265mmx185mmx150mm)ExamVue PACS2020-04-10
08809413810488Box for ExamVue DR(outside 265mmx185mmx150mm)ExamVue DR2020-04-10
08809413810464Radiographic GridGrid-30002020-04-06

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
08809413810235Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810242Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810259Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01