FDA.reportPublic FDA data

APERTO Lucent

Primary DI
04573596200940
Brand
APERTO Lucent
Company
FUJIFILM CORPORATION
Model
MR-QWC-81
Catalog number
Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter
Device description
Receiver Coil
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573596200940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573596200940045735962009404573596200940

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, permanent magnetA general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
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
14547410566458FUJIFILMDH-134STR2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596200865APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200889APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200896APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200902APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200964APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596200971APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201480APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201497APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596201503APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202210APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
04573596202227APERTO LucentFUJIFILM CORPORATIONLNH2026-05-22
07090042053051BatteryBoxNordicneurolab ASLNH2026-04-01
07090042053068HeadSet 3TNordicneurolab ASLNH2026-04-01
07090042053075BatteryChargerNordicneurolab ASLNH2026-04-01
07090042053082AccessPointNordicneurolab ASLNH2026-04-01
07090042053099AudioHubNordicneurolab ASLNH2026-04-01
00857534006929Neuro II-SEIMRIS Imaging, Inc.LNH2026-03-20
B66910103G TransducerMRIAUDIO, INC.LNH2026-03-06
B6693300MRIaudio Over-Ear HeadphonesMRIAUDIO, INC.LNH2026-03-06
B66915070MRIaudioMRIAUDIO, INC.LNH2026-03-03
04068151995268MAGNETOM LuminaSiemens Healthineers AGLNH2026-02-23
04068151995312MAGNETOM Sola FitSiemens Healthineers AGLNH2026-02-23
00884838104402IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-27
04056869299594MAGNETOM Flow.NeoSiemens Healthcare GmbHLNH2026-01-19
04068151034196MAGNETOM Flow.EliteSiemens Healthcare GmbHLNH2026-01-19
00884838128415Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128422Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128439Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128446Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128453Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07