APERTO Lucent MRI System— 510(k) K261283
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K261283 for APERTO Lucent MRI System, Substantially Equivalent on 2026-09-16. Applicant: Fujifilm Corporation. Device class: 2.
Summary
APERTO Lucent MRI System comes from Fujifilm Corporation under product code LNH (System, Nuclear Magnetic Resonance Imaging). The record has no detail on the system beyond its name and code.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Fujifilm filed from Minato-Ku, Japan. The decision came 152 calendar days after receipt (April 17 to September 16, 2026).
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minato-Ku, JP
Recent devices under product code LNH
view allMore clearances from Fujifilm Corporation
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . 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.