Cleared Traditional

K041022 - NEUROQ - PET DP

K041022 is an FDA 510(k) clearance for NEUROQ - PET DP, 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 58-day FDA review.

K041022 · Syntermed, Inc. · Radiology device
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Jun 2004
Decision
58d
Days
Class 2
Risk

K041022 is an FDA 510(k) clearance for the NEUROQ - PET DP. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Syntermed, Inc. (Atlanta, US). The FDA issued a Cleared decision on June 17, 2004 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syntermed, Inc. devices

FDA 510(k) Submission Details - K041022

510(k) Number K041022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2004
Decision Date June 17, 2004
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 290
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K041022.
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
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GEMINI PET/CT IMAGING SYSTEM
K041955 · Philips Medical Systems (Cleveland), Inc. · Jul 2004
GE DISCOVERY ST
K041543 · Ge Healthcare · Jun 2004
GE DISCOVERY ST SYSTEM
K041220 · GE Medical Systems · Jun 2004
ECAT HRRT
K040933 · Cti Pet Systems, Inc. · Jun 2004
GRIFFIN SPECT/CT IMAGING SYSTEM
K041218 · Adac Laboratories · May 2004