Cleared Traditional

K122241 - IMAGEN3D

K122241 is an FDA 510(k) clearance for IMAGEN3D, manufactured by Cardiovascular Imaging Technologies. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K122241 · Cardiovascular Imaging Technologies · Radiology device
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Oct 2012
Decision
89d
Days
Class 2
Risk

K122241 is an FDA 510(k) clearance for the IMAGEN3D. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cardiovascular Imaging Technologies (Lenexa, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 89 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 Cardiovascular Imaging Technologies devices

FDA 510(k) Submission Details - K122241

510(k) Number K122241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date October 24, 2012
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
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 359
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