Cleared Traditional

K903661 - BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

K903661 is an FDA 510(k) clearance for BRUKER R-28, manufactured by Bruker Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K903661 · Bruker Medical Imaging, Inc. · Radiology device
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Nov 1990
Decision
92d
Days
Class 2
Risk

K903661 is an FDA 510(k) clearance for the BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD. 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 November 13, 1990 after a review of 92 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 Bruker Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K903661

510(k) Number K903661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date November 13, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
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 1007
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