FDA.reportPublic FDA data

DR-ID 601SE

Primary DI
04547410256840
Brand
DR-ID 601SE
Company
FUJIFILM CORPORATION
Model
DR-ID 601 SE A W E
Device description
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid state x-ray imager (flat panel/digital imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410256840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410256840045474102568404547410256840

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
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
04547410571134FDR AQRODR-XD 1000 MBL ES US E2026-03-20
14547410566250FUJIFILMDH-084STR2026-02-27
14547410566298FUJIFILMDH-094STR2026-02-27
14547410566335FUJIFILMDH-104STR2026-02-27
14547410566373FUJIFILMDH-114STR2026-02-27
14547410566410FUJIFILMDH-124STR2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800018408209EXPD 4343SDRTECH CorporationMQB2026-03-17
08800018408308EXPD 4343DDRTECH CorporationMQB2026-03-17
08800018408407EXPD 3643DDRTECH CorporationMQB2026-03-17
04549292223774CANON INC.CANON INC.MQB2026-02-06
00854344007795Varex Digital Imaging Software, Nexus DR, v4.19VAREX IMAGING CORPORATIONMQB2026-01-16
04719879300130YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300147YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300154YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
04719879300161YushanINNOCARE OPTOELECTRONICS CORPORATIONMQB2025-12-08
08800069500105BONX805, DIONE-X80 Portable X-ray Imaging Devicebontech IncMQB2025-12-03
00854344007771Varex Digital Imaging Software, Nexus DR, v4.18VAREX IMAGING CORPORATIONMQB2025-11-13
08800069500013BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500020BSD3543 Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500037BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500044BSD4343R Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500051BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
08800069500068BSD3543W Digital Flat Panel X-ray Detectorbontech IncMQB2025-09-11
04547410484786FDR D-EVO III G35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484793FDR D-EVO III G43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484809FDR D-EVO III C35iFUJIFILM CORPORATIONMQB2025-08-29
04547410484816FDR D-EVO III C43iFUJIFILM CORPORATIONMQB2025-08-29
04547410484823FDR D-EVO III C25iFUJIFILM CORPORATIONMQB2025-08-29
04547410511673FDR D-EVO III G80iFUJIFILM CORPORATIONMQB2025-08-29
04547410515176DR-ID 1200MCFUJIFILM CORPORATIONMQB2025-08-29
08800018430002EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430101EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430200EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430309EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430408EXPD-N seriesDRTECH CorporationMQB2025-06-13
08800018430507EXPD-N seriesDRTECH CorporationMQB2025-06-13