Cleared Traditional

MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 (K895328) - FDA 510(k) Clearance

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

K895328 · Bruker Medical Imaging, Inc. · Radiology device
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Mar 1990
Decision
190d
Days
Class 2
Risk

K895328 is an FDA 510(k) clearance for the MAGNETIC RESONANCE SYSTEM MODEL BMT-1100. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Bruker Medical Imaging, Inc. (Lisle, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 190 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 Bruker Medical Imaging, Inc. devices

Submission Details

510(k) Number K895328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date March 09, 1990
Days to Decision 190 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 107d · This submission: 190d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K895328.
GE SIGNA ADVANTAGE
K901730 · GE Medical Systems · Jul 1990
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