Cleared Traditional

MT/S SOFTWARE RELEASE 5.0. (K893518) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893518 · Diasonics, Inc. · Radiology device
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Oct 1989
Decision
172d
Days
Class 2
Risk

K893518 is an FDA 510(k) clearance for the MT/S SOFTWARE RELEASE 5.0.. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Diasonics, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 172 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 Diasonics, Inc. devices

Submission Details

510(k) Number K893518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date October 27, 1989
Days to Decision 172 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 107d · This submission: 172d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K893518.
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · Siemens Medical Solutions USA, Inc. · Nov 1989
GE MR MAX SYSTEM
K895794 · GE Medical Systems · Nov 1989
VISTA MR 2055 HP SYSTEM
K895151 · Philips Medical Systems (Cleveland), Inc. · Oct 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · Siemens Medical Solutions USA, Inc. · Oct 1989
GE SIGNA ADVANTAGE
K893509 · GE Medical Systems · Aug 1989
SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM
K893640 · Siemens Medical Solutions USA, Inc. · Aug 1989