Cleared Traditional

K883621 - INSTRUMENTARIUM ULF MR IMAGING SYSTEM

K883621 is the FDA 510(k) clearance for INSTRUMENTARIUM ULF MR IMAGING SYSTEM by Instrumentarium Corp.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K883621 · Instrumentarium Corp. · Radiology device
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Nov 1988
Decision
77d
Days
Class 2
Risk

K883621 is an FDA 510(k) clearance for the INSTRUMENTARIUM ULF MR IMAGING SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Instrumentarium Corp. (Washington, US). The FDA issued a Cleared decision on November 10, 1988 after a review of 77 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 Instrumentarium Corp. devices

Submission Details

510(k) Number K883621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1988
Decision Date November 10, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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 818
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K883621.
CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL
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K883482 · Philips Medical Systems (Cleveland), Inc. · Oct 1988
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K883519 · Philips Medical Systems (Cleveland), Inc. · Oct 1988
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K883516 · Diasonics, Inc. · Oct 1988