Cleared Traditional

NEUROSPECTQUAD GAMMA CAMERA (K013353) - FDA 510(k) Clearance

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

K013353 · Nuclear Cardiology Systems, Inc. · Radiology device
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Mar 2002
Decision
146d
Days
Class 2
Risk

K013353 is an FDA 510(k) clearance for the NEUROSPECTQUAD GAMMA CAMERA. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Nuclear Cardiology Systems, Inc. (Boulder, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Nuclear Cardiology Systems, Inc. devices

Submission Details

510(k) Number K013353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date March 04, 2002
Days to Decision 146 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
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 172
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K013353.
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GE DISCOVERY LS SYSTEM
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GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · General Electric Co. · Sep 2002
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · GE Medical Systems · Sep 2001
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001