APERTO Lucent APERTO Lucent

GUDID 04573596200704

Magnetic Resonance Diagnostic Device

FUJIFILM CORPORATION

Full-body MRI system, permanent magnet
Primary Device ID04573596200704
NIH Device Record Keydd406d91-9e34-42ce-be13-bce2b15a7b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPERTO Lucent
Version Model NumberAPERTO Lucent
Catalog NumberAPERTO Lucent
Company DUNS713565195
Company NameFUJIFILM CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104573596200704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-27
Device Publish Date2024-09-19

Devices Manufactured by FUJIFILM CORPORATION

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14547410528265 - FUJIFILM2024-09-30 FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the
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04573596200704 - APERTO Lucent2024-09-27 Magnetic Resonance Diagnostic Device
04573596204368 - ECHELON Synergy2024-09-19 Magnetic Resonance Diagnostic Device
04547410530582 - DR-ID 1281SE2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d
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