Cleared Traditional

K962481 - QUASAR RECOVERY IMAGING PACKAGE

K962481 is an FDA 510(k) clearance for QUASAR RECOVERY IMAGING PACKAGE, 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 154-day FDA review.

K962481 · Trionix Research Laboratory, Inc. · Radiology device
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Nov 1996
Decision
154d
Days
Class 2
Risk

K962481 is an FDA 510(k) clearance for the QUASAR RECOVERY IMAGING PACKAGE. 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 27, 1996 after a review of 154 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 - K962481

510(k) Number K962481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date November 27, 1996
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
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 K962481.
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · Elscint, Inc. · Jan 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · GE Medical Systems · Jan 1997
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · Toshiba Medical Systems · Dec 1996
QUANTEM
K963162 · Elscint, Inc. · Nov 1996
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964265 · Trionix Research Laboratory, Inc. · Nov 1996
BIAD NUCLEAR IMAGING SYSTEM
K964266 · Trionix Research Laboratory, Inc. · Nov 1996