Cleared Traditional

K895629 - MODEL 8100

Also marketed or referenced as:
UPPER EXTREMITY COIL

K895629 is an FDA 510(k) clearance for MODEL 8100, manufactured by Medical Advances, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K895629 · Medical Advances, Inc. · Radiology device
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Feb 1990
Decision
136d
Days
Class 2
Risk

K895629 is an FDA 510(k) clearance for the MODEL 8100. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medical Advances, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 136 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 Medical Advances, Inc. devices

FDA 510(k) Submission Details - K895629

510(k) Number K895629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date February 02, 1990
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 997
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K895629.
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MRT 50A CRANIO-CERVICAL COIL
K900287 · Toshiba America Mri, Inc. · Mar 1990
MODEL: GYREX VERSION V
K896419 · Elscint, Inc. · Feb 1990
MODEL 6000
K896789 · Medical Advances, Inc. · Jan 1990
MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC
K896309 · Instrumentarium Imaging, Inc. · Jan 1990