Cleared Traditional

K072307 - QUANTITATIVE NEUROQ 3.0

K072307 is an FDA 510(k) clearance for QUANTITATIVE NEUROQ 3.0, manufactured by Syntermed, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K072307 · Syntermed, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
210d
Days
Class 2
Risk

K072307 is an FDA 510(k) clearance for the QUANTITATIVE NEUROQ 3.0. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Syntermed, Inc. (Anaheim, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 210 days - an extended review cycle.

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 Syntermed, Inc. devices

FDA 510(k) Submission Details - K072307

510(k) Number K072307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date March 14, 2008
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

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 289
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K072307.
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · Philips Medical Systems (Cleveland), Inc. · Jun 2008
GEMINI CONDOR
K081135 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
BRIGHTVIEW VCT IMAGING SYSTEM
K080927 · Philips Medical Systems (Cleveland), Inc. · Apr 2008
VENTRI 1.1
K080124 · Ge Medical Systems F.I. Haifa · Jan 2008
SYMBIA-E, MODEL 10275879
K072567 · Siemens Medical Solutions USA, Inc. · Oct 2007
BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
K071068 · Siemens Medical Solutions USA, Inc. · May 2007