FDA.reportPublic FDA data

FUJI MEDICAL DRY FILM

Primary DI
04547410265989
Brand
FUJI MEDICAL DRY FILM
Company
FUJIFILM CORPORATION
Model
DI-ML 20X25 150 *
Catalog number
4741026598
Device description
MEDICAL DRY IMAGING FILM 150NIF 20x25
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMCCamera, multi format, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033377000FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP LFujifilm Medical System U.S.A., Inc.2004-01-09LMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547410265986PackageGS15In Commercial Distribution
04547410265989PrimaryGS10
84547410265985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454741026598614547410265986
04547410265989045474102659894547410265989
8454741026598584547410265985

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic-imaging multiformat cameraAn electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(800)272-8465xxx@xxx.xxx

Regulatory Flags#

DUNS number
713565195
Device count
150
Lot or batch
true
Expiration date on label
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
04547410431957DRYPIX SmartFUJIFILM CORPORATIONLMC2024-06-07
04560141950474DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2022-07-06
60889976571002DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-08-02
60889976559352DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-04-28
04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141932494DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141945630DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141945647DRYPRO SIGMA 2KONICA MINOLTA, INC.LMC2016-10-05
04560141921641DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141922686DRYPRO MODEL 832KONICA MINOLTA, INC.LMC2016-09-19
04560141923119DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
04560141923126DRYPRO MODEL 873KONICA MINOLTA, INC.LMC2016-09-19
04547410080520FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080551FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080773FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410080797FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142433FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410142457FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222494FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222548FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222555FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222562FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410222579FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
04547410265965FUJI MEDICAL DRY FILMFUJIFILM CORPORATIONLMC2016-09-16
60889971020178DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971033840DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971046024DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055378DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889971055392DRYVIEW 5950 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16
60889976559345DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2016-09-16