Cleared Traditional

K050366 - IMAGENPRO

K050366 is an FDA 510(k) clearance for IMAGENPRO, manufactured by Cardiovascular Imaging Technologies, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K050366 · Cardiovascular Imaging Technologies, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
31d
Days
Class 2
Risk

K050366 is an FDA 510(k) clearance for the IMAGENPRO. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cardiovascular Imaging Technologies, LLC (Lee'S Summit, US). The FDA issued a Cleared decision on March 17, 2005 after a review of 31 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, LLC devices

FDA 510(k) Submission Details - K050366

510(k) Number K050366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date March 17, 2005
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 324
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K050366.
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GE DISCOVERY VCT SYSTEM
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INFINIA LIGHTSPEED
K043381 · Ge Medical Systems F.I. Haifa · Dec 2004
GEMINI GXL
K042935 · Philips Medical Systems (Cleveland), Inc. · Nov 2004