APERTO Lucent MRI System
FDA 510(k) K253862 · Fujifilm Corporation
510(k) numberK253862
Submission
- Device name
- APERTO Lucent MRI System
- Applicant
- Fujifilm Corporation
Minato-Ku, JP - Received
- December 3, 2025
- Decision date
- April 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was APERTO Lucent MRI System cleared by the FDA?
APERTO Lucent MRI System (K253862) received a 510(k) decision of Substantially Equivalent on April 6, 2026, 124 days after the submission was received.
What is the product code of K253862?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.