APERTO Lucent MRI System— 510(k) K253862

Name: FDA 510(k) clearance K253862
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K253862 for APERTO Lucent MRI System, Substantially Equivalent on 2026-04-06. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2025-12-03
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minato-Ku, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

More clearances from Fujifilm Corporation

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K253836 — FCT iStream Phase 22026-09-04
K261170 — BA-004CC2026-08-12
K260567 — EW10-EC02 Endoscopy Support Program2026-08-07
K261880 — FUJIFILM Processor EP-8000; Balloon Controller PB-30; Endoscopy Support Program EW10-VM012026-07-02
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.