Cleared Traditional

K041840 - MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM

K041840 is an FDA 510(k) clearance for MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM, manufactured by Medx, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K041840 · Medx, Inc. · Radiology device
Download Printable Device Report (PDF)
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Aug 2004
Decision
43d
Days
Class 2
Risk

K041840 is an FDA 510(k) clearance for the MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Medx, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on August 20, 2004 after a review of 43 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 Medx, Inc. devices

FDA 510(k) Submission Details - K041840

510(k) Number K041840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2004
Decision Date August 20, 2004
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
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 321
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K041840.
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GE DISCOVERY ST
K041543 · Ge Healthcare · Jun 2004
GE DISCOVERY ST SYSTEM
K041220 · GE Medical Systems · Jun 2004