Cleared Traditional

K905634 - SMT-50X

K905634 is an FDA 510(k) clearance for SMT-50X, manufactured by Shimadzu Medical Systems. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K905634

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.

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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 977
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
10 ADJUSTABLE BELT COIL
K910269 · Resonex, Inc. · 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