Cleared Traditional

K233629 - APERTO Lucent MRI System

K233629 is an FDA 510(k) clearance for APERTO Lucent MRI System, manufactured by Fujifilm Healthcare Americas Corporation. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K233629 · Fujifilm Healthcare Americas Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
179d
Days
Class 2
Risk

K233629 is an FDA 510(k) clearance for the APERTO Lucent MRI System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Fujifilm Healthcare Americas Corporation (Lexington, US). The FDA issued a Cleared decision on May 10, 2024 after a review of 179 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Healthcare Americas Corporation devices

FDA 510(k) Submission Details - K233629

510(k) Number K233629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date May 10, 2024
Days to Decision 179 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

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All 840
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