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

14547410566250 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410566298 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410566335 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410566373 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410566410 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410566458 - FUJIFILM2026-03-09 These hoods are intended to be used in combination with the compatible endoscope to maintain the field of view during endoscopic
14547410520580 - FUJIFILM2026-02-02 This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trach
14547410564119 - FUJIFILM2026-01-22 This product is an accessory designed to be attached to a left/right angulation knob of a FUJIFILM compatible endoscope, and to
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