Cleared Traditional

K964268 - TRIAD 88 NUCLEAR IMAGING SYSTEM

K964268 is an FDA 510(k) clearance for TRIAD 88 NUCLEAR IMAGING SYSTEM, 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 19-day FDA review.

K964268 · Trionix Research Laboratory, Inc. · Radiology device
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Nov 1996
Decision
19d
Days
Class 2
Risk

K964268 is an FDA 510(k) clearance for the TRIAD 88 NUCLEAR IMAGING SYSTEM. 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 November 12, 1996 after a review of 19 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 Trionix Research Laboratory, Inc. devices

FDA 510(k) Submission Details - K964268

510(k) Number K964268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date November 12, 1996
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
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 K964268.
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
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BIAD NUCLEAR IMAGING SYSTEM
K964266 · Trionix Research Laboratory, Inc. · Nov 1996
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964267 · Trionix Research Laboratory, Inc. · Nov 1996
GAMMACON IMAGE TRANSLATION SYSTEM
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ECAT EXACT & ECAT EXACT HR+
K962797 · Cti Pet Systems, Inc. · Oct 1996
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
K962738 · GE Medical Systems · Oct 1996