FDA.reportPublic FDA data

15X30 IP ADAPTER

Primary DI
04547410222104
Brand
15X30 IP ADAPTER
Company
FUJIFILM CORPORATION
Model
IR ADAPTER FOR IP 15X30CM E
Catalog number
47410-22210
Device description
Inserting the Fuji Imaging Plate ST-VI 15cmx30cm into the adapter to insert it into 35cmx43cm cassette makes image reading in the Fuji Computed Radiography possible.
Published
2016-09-23
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
EAMScreen, Intensifying, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAMScreen, Intensifying, RadiographicRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862414000FUJI CR IMAGING PLATEParexel Intl. Corp.1987-02-26EAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547410222101PackageGS110In Commercial Distribution
04547410222104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741022210114547410222101
04547410222104045474102221044547410222104

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 photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.

Contacts#

Phone, Email table
PhoneEmail
+018002728465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22
04573596201480APERTO LucentMR-QHC-81RQD Head coil R MR-QHC-81R for APERTO Lucent2026-05-22
04573596201497APERTO LucentMR-QKC-83RQD Knee coil R MR-QKC-83R for APERTO Lucent2026-05-22
04573596201503APERTO LucentMR-IBC-83Open body coil MR-IBC-83 for APERTO Lucent/APERTO 2026-05-22
04573596202210APERTO LucentMR-QFC-82NFlexible Body coil N(M) MR-QFC-82N for APERTO Luce2026-05-22
04573596202227APERTO LucentMR-QFC-83NFlexible Body coil N(L) MR-QFC-83N for APERTO Luce2026-05-22
04573596200704APERTO LucentAPERTO LucentAPERTO Lucent2024-09-19
04547410334494Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B15-2016-09-16
04547410334500Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B20-2016-09-16
04547410334517Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B25-2016-09-16
04547410334524Fujifilm Diathermic Slitter (FlushKnife)DK2618J -B30-2016-09-16
04547410334531Fujifilm Diathermic Slitter (FlushKnife)DK2618J -N10-2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889813062005Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00889813062012Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00889813062029Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062002Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062019Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062026Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
00817169023531Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024484Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024491Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024507Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024514Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024521Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169025016Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169023593Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023609Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023616Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023623Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169025009Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023586Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
40889978979543Flexible Phosphor Screen GP-2CARESTREAM HEALTH, INC.EAM2021-06-27
60889978979547Flexible Phosphor Screen GP-2CARESTREAM HEALTH, INC.EAM2021-06-27
00843696119577Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119591Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119607Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119614Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119621Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696119638Wolf X-RayFlow X Ray CorporationEAM2020-09-26
00843696115005Wolf X-RayFlow X Ray CorporationEAM2020-09-25
00843696115012Wolf X-RayFlow X Ray CorporationEAM2020-09-25
00843696115029Wolf X-RayFlow X Ray CorporationEAM2020-09-25