Cleared Traditional

K964438 - 511 KEV COLLIMATOR

K964438 is an FDA 510(k) clearance for 511 KEV COLLIMATOR, 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 205-day FDA review.

K964438 · Trionix Research Laboratory, Inc. · Radiology device
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May 1997
Decision
205d
Days
Class 2
Risk

K964438 is an FDA 510(k) clearance for the 511 KEV COLLIMATOR. 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 May 29, 1997 after a review of 205 days - an extended review 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: 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 - K964438

510(k) Number K964438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date May 29, 1997
Days to Decision 205 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
98d slower than avg
Panel avg: 107d · This submission: 205d
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 K964438.
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E. CAM PROFILE ATTENUATION CORRECTION
K963983 · Siemens Corp. · Mar 1997