Cleared Traditional

K171597 - Vantage Elan 1.5T, V4.0

K171597 is an FDA 510(k) clearance for Vantage Elan 1.5T, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K171597 · Toshibamedical Systems Corporation · Radiology device
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Jul 2017
Decision
51d
Days
Class 2
Risk

K171597 is an FDA 510(k) clearance for the Vantage Elan 1.5T, V4.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on July 21, 2017 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K171597

510(k) Number K171597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date July 21, 2017
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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.

Regulatory Consultant

Toshiba America Medical Systems, In.C
Paul Biggins

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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