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APERTO Lucent MRI System

by Fujifilm Corporation

510(k) K253862Ref Joint coil (M) MR-JCR-82 for APERTO Lucent, Wrist coil MR-QWC-81 for APERTO Lucent, Joint coil (ML) MR-JCR-82L for APERTO Lucent, Shoulder coil MR-MSC-81 for APERTO Lucent, Open Body coil MR-IBC-83 for APERTO Lucent, C-Spine coil MR-CSC-81 for APERTO Lucent, Joint coil (S) MR-JC-81 for APERTO Lucent, Knee coil MR-QKC-83RC for APERTO Lucent, APERTO Lucent, Flexible Body coil N(L) MR-QFC-83N for APERTO Lucent, QD Knee coil R MR-QKC-83R for APERTO Lucent, Joint coil (L) MR-JCR-83 for APERTO Lucent

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253862↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number457359620103000000000052V Basic UDI-DI Date4 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253862 Date6 Apr 2026ClearedStatusActive
United StatesGUDID listing GUDID Number04573596200865 UDI-DI Date19 Sep 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
APERTO Lucent
Generic Name
Full-body MRI system, permanent magnet
Model / Ref / Catalog
APERTO Lucent, Joint coil (M) MR-JCR-82 for APERTO Lucent, Wrist coil MR-QWC-81 for APERTO Lucent, Joint coil (ML) MR-JCR-82L for APERTO Lucent, Shoulder coil MR-MSC-81 for APERTO Lucent, Open Body coil MR-IBC-83 for APERTO Lucent, C-Spine coil MR-CSC-81 for APERTO Lucent, Joint coil (S) MR-JC-81 for APERTO Lucent, Knee coil MR-QKC-83RC for APERTO Lucent, Flexible Body coil N(L) MR-QFC-83N for APERTO Lucent, QD Knee coil R MR-QKC-83R for APERTO Lucent, Joint coil (L) MR-JCR-83 for APERTO Lucent, MR-QFC-83N, MR-IBC-83, MR-QKC-83R, MR-MSC-81, MR-QWC-81, MR-CSC-81, MR-JCR-83, MR-JC-81, MR-JCR-82, Open Body coil MR-IBC-83 for APERTO Lucent/APERTO Eterna/Aperto, Knee coil MR-QKC-83R for APERTO Lucent, Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO Eterna/Aperto, Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eterna/Aperto, C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Eterna/Aperto, Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT Eterna/Aperto, Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Eterna/Aperto, Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT Eterna/Aperto
Primary DI / UDI-DI
04573596200865, 04573596200940, 04573596202531, 04573596200964, 04573596201503, 04573596200902, 04573596200889, 04573596202555, 04573596200711, 04573596202227, 04573596201497, 04573596200896, 04573596200704
Basic UDI-DI
457359620103000000000052V
510(k) Number
FDA Product Code
LNH
EMDN Code
Z11050102 Open magnet MRI scanners with magnetic field intensity less than or equal to 0.5t
GMDN Term
Full-body MRI system, permanent magnet
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1000
EU market of registration
Netherlands
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II
Contains LatexEUDAMED
No
Yes
510(k)
—
GUDID
No

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The APERTO Lucent MRI System is a Nuclear Magnetic Resonance Imaging device, classified as a Class II medical device. It generates detailed images of the internal structures of the human body using strong magnetic fields and radio waves, enabling diagnostic evaluation of organs, tissues, and skeletal systems for clinical assessment.

This system is designed for use in radiology departments within hospital or clinical settings. It is supplied as a reusable, non-sterile device and is MRI-safe, adhering to strict electromagnetic compatibility standards. The system operates across multiple configurations, as indicated by its registration numbers, and has received FDA 510(k) clearance and MDR authorization. Storage and maintenance follow manufacturer guidelines to ensure consistent performance and safety.

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Properties

  • Contains Latex NoEUDAMEDGUDIDYesEUDAMED
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No