FDA.reportPublic FDA data

ECHELON OVAL

Primary DI
04573596200773
Brand
ECHELON OVAL
Company
FUJIFILM HEALTHCARE CORPORATION
Model
ECHELON OVAL
Published
2021-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
04580292768391PreviousGS10
04573596200773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580292768391045802927683914580292768391
04573596200773045735962007734573596200773

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
718262719
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
04573596204382FUJIFILMFCT iStream 2024-07-12
04573596212011L31KPL31KP2024-01-25
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212035L35L352024-01-22
04573596212455UST-2266-5UST-2266-52024-01-22
04573596214176CL4416R1CL4416R12024-01-22
04573596214336C421C4212024-01-22
04573596214503CC41R2CC41R22024-01-22
04573596214510C253AC253A2024-01-22
04573596214527ARIETTA x10ARIETTA x102024-01-22
04573596212691UST-5311-TIPUST-5311-TIP2022-09-09
04573596214381ARIETTA 650ARIETTA 6502022-02-07
04573596213247UST-9113P-3.5UST-9113P-3.52021-07-19
04573596210062ASU-1013ASU-10132021-07-18
04573596210079ASU-1014ASU-10142021-07-18
04573596210116BA-001BA-0012021-07-18
04573596210260MP-2448MP-24482021-07-17
04573596210345MP-2456MP-24562021-07-17
04573596210352MP-2458MP-24582021-07-17
04573596210376MP-2473MP-24732021-07-17

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
04573596200940APERTO 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