Cleared Traditional

K913463 - MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN

K913463 is an FDA 510(k) clearance for MAG RES IMAG SYST/BRUKER MODEL R28 WHOL..., 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 116-day FDA review.

K913463 · Bruker Medical Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
116d
Days
Class 2
Risk

K913463 is an FDA 510(k) clearance for the MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Bruker Medical Imaging, Inc. (Billerica, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 116 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 - K913463

510(k) Number K913463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date November 29, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
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
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K913463.
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
K913770 · General Electric Co. · Dec 1991
MAGNETOM 42 SP,63 SP,IMPACT
K915112 · Siemens Medical Solutions USA, Inc. · Dec 1991
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)
K914114 · Resonex, Inc. · Dec 1991
MRT-150A
K914012 · Toshiba America Mri, Inc. · Nov 1991
MODEL 311GE-64: WHOLE VOLUME NECK COIL
K914535 · Medical Advances, Inc. · Nov 1991
MODELS 190GE-64/191GE-64/192GE-64/193GE-64
K914536 · Medical Advances, Inc. · Nov 1991