Cleared Special

QED DIODE DETECTORS, MODELS 1112-1116 (K011466) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011466 · Sun Nuclear Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
23d
Days
Class 2
Risk

K011466 is an FDA 510(k) clearance for the QED DIODE DETECTORS, MODELS 1112-1116. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Sun Nuclear Corp. (Melbourne, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sun Nuclear Corp. devices

Submission Details

510(k) Number K011466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date June 06, 2001
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 432
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K011466.
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BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · Siemens Medical Solutions USA, Inc. · May 2001
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K010691 · Philips Medical Systems (Cleveland), Inc. · May 2001
INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
K003853 · Philips Medical Systems (Cleveland), Inc. · Feb 2001