Cleared Traditional

K925987 - INSTRUMENTARIUM MEGA4 HT

K925987 is an FDA 510(k) clearance for INSTRUMENTARIUM MEGA4 HT, manufactured by Instrumentarium Imaging, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K925987 · Instrumentarium Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
175d
Days
Class 2
Risk

K925987 is an FDA 510(k) clearance for the INSTRUMENTARIUM MEGA4 HT. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Instrumentarium Imaging, Inc. (Highland Heights, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 175 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 Instrumentarium Imaging, Inc. devices

FDA 510(k) Submission Details - K925987

510(k) Number K925987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date May 19, 1993
Days to Decision 175 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
68d slower than avg
Panel avg: 107d · This submission: 175d
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 840
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K925987.
MRH-1500
K922846 · Hitachi Medical Systems America, Inc. · Jun 1993
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K924605 · General Electric Co. · May 1993
MRINNERVU ENDORECTAL PROSTATE COIL
K925029 · Medrad, Inc. · May 1993
INSTRUMENTARIUM MEGA4 HT
K924921 · Instrumentarium Imaging, Inc. · May 1993
INSTRUMENTARIUM MEGA4 HT
K923581 · Instrumentarium Imaging, Inc. · May 1993
INSTRUMENTARIUM MEGA4 HT
K924472 · Instrumentarium Imaging, Inc. · May 1993