Cleared Traditional

K152503 - ImagenSPECT

K152503 is an FDA 510(k) clearance for ImagenSPECT, 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 145-day FDA review.

K152503 · Cardiovascular Imaging Technologies · Radiology device
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Jan 2016
Decision
145d
Days
Class 2
Risk

K152503 is an FDA 510(k) clearance for the ImagenSPECT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cardiovascular Imaging Technologies (Kansas City, US). The FDA issued a Cleared decision on January 25, 2016 after a review of 145 days - within the typical 510(k) review window.

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 Cardiovascular Imaging Technologies devices

FDA 510(k) Submission Details - K152503

510(k) Number K152503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2015
Decision Date January 25, 2016
Days to Decision 145 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
38d slower than avg
Panel avg: 107d · This submission: 145d
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 Consultant

Pra Health Sciences
MELANIE HASEK

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 359
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MAMMI
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