APERTO Lucent MRI System
FDA 510(k) K233629 · FUJIFILM Healthcare Americas Corporation
510(k) numberK233629
Submission
- Device name
- APERTO Lucent MRI System
- Applicant
- FUJIFILM Healthcare Americas Corporation
Lexington, MA, US - Received
- November 13, 2023
- Decision date
- May 10, 2024
- 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 (K233629) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 179 days after the submission was received.
What is the product code of K233629?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.