Cleared Traditional

K961597 - GATED MIBI 3-D EJECTION FRACTION PROCESSING

K961597 is an FDA 510(k) clearance for GATED MIBI 3-D EJECTION FRACTION PROCESSING, manufactured by Trionix Research Laboratory, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K961597 · Trionix Research Laboratory, Inc. · Radiology device
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Sep 1996
Decision
133d
Days
Class 2
Risk

K961597 is an FDA 510(k) clearance for the GATED MIBI 3-D EJECTION FRACTION PROCESSING. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Trionix Research Laboratory, Inc. (Twinsburg, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 133 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 Trionix Research Laboratory, Inc. devices

FDA 510(k) Submission Details - K961597

510(k) Number K961597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date September 04, 1996
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
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 356
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K961597.
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SPECTEF PROTOCOL
K954874 · GE Medical Systems · Feb 1996