Cleared Traditional

K905634 - SMT-50X

K905634 is the FDA 510(k) clearance for SMT-50X by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K905634 · Shimadzu Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
114d
Days
Class 2
Risk

K905634 is an FDA 510(k) clearance for the SMT-50X. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on April 10, 1991 after a review of 114 days - within the typical 510(k) review window.

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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K905634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1990
Decision Date April 10, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K905634.
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
K911642 · Hitachi Medical Systems America, Inc. · May 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
K911667 · Hitachi Medical Systems America, Inc. · May 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817 · General Electric Co. · Apr 1991
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
K910220 · Toshiba America Mri, Inc. · Mar 1991
MAGNETOM 42 SP AND 63 SP
K910498 · Siemens Medical Solutions USA, Inc. · Mar 1991
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
K910513 · Medical Advances, Inc. · Mar 1991