Cleared Traditional

K884607 - MT/S (SOFTWARE RELEASE 3.1)

K884607 is an FDA 510(k) clearance for MT/S (SOFTWARE RELEASE 3.1), manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K884607 · Diasonics, Inc. · Radiology device
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Dec 1988
Decision
47d
Days
Class 2
Risk

K884607 is an FDA 510(k) clearance for the MT/S (SOFTWARE RELEASE 3.1). 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 December 21, 1988 after a review of 47 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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K884607

510(k) Number K884607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date December 21, 1988
Days to Decision 47 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
60d faster than avg
Panel avg: 107d · This submission: 47d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K884607.
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816 · Diasonics, Inc. · Feb 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · Siemens Medical Solutions USA, Inc. · Jan 1989
MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
K884484 · Siemens Medical Solutions USA, Inc. · Jan 1989
MT/S (SPINE TRANSMIT COIL)
K884606 · Diasonics, Inc. · Dec 1988
TEMPOROMANDIBULAR JOINT COIL (TMJ)
K884743 · Diasonics, Inc. · Dec 1988
GE MR MAX SYSTEM
K883547 · General Electric Co. · Nov 1988