Cleared Traditional

MODEL 8100 (K895629) - FDA 510(k) Clearance

Also marketed or referenced as:
UPPER EXTREMITY COIL

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

K895629 · Medical Advances, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K895629.
ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63
K901818 · Siemens Medical Solutions USA, Inc. · May 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K900889 · Siemens Medical Solutions USA, Inc. · Mar 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064 · Philips Medical Systems (Cleveland), Inc. · Mar 1990
VISTA MR 2055 HP SYSTEM
K896508 · Philips Medical Systems (Cleveland), Inc. · Jan 1990
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