Cleared Traditional

K183657 - Vantage Galan 3T

K183657 is the FDA 510(k) clearance for Vantage Galan 3T by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K183657 · Canon Medical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
78d
Days
Class 2
Risk

K183657 is an FDA 510(k) clearance for the Vantage Galan 3T, MRT-3020/A9, V5.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on March 15, 2019 after a review of 78 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 Canon Medical Systems Corporation devices

Submission Details

510(k) Number K183657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date March 15, 2019
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Canon Medical Systems USA, Inc.
Janine F. Reyes

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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K183657.
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
K190461 · Philips Medical Systems Nederland B.V. · Jun 2019
MAGNETOM Avanto Fit
K190757 · Siemens Medical Solution USA, Inc. · May 2019
uMR 780, uMR 790
K191157 · Shanghai United Imaging Healthcare Co., Ltd. · May 2019
EMMA 1.5T MRI System
K183621 · Time Medical Limited · Feb 2019
MAGNETOM Terra
K183222 · Siemens Medical Solutions USA, Inc. · Feb 2019
MAGNETOM Aera
K190138 · Siemens Medical Solutions USA, Inc. · Feb 2019