Cleared Traditional

K963162 - QUANTEM

K963162 is an FDA 510(k) clearance for QUANTEM, manufactured by Elscint, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963162 · Elscint, Inc. · Radiology device
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Nov 1996
Decision
90d
Days
Class 2
Risk

K963162 is an FDA 510(k) clearance for the QUANTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on November 12, 1996 after a review of 90 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 Elscint, Inc. devices

FDA 510(k) Submission Details - K963162

510(k) Number K963162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date November 12, 1996
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 386
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K963162.
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · GE Medical Systems · Jan 1997
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · Toshiba Medical Systems · Dec 1996
QUASAR RECOVERY IMAGING PACKAGE
K962481 · Trionix Research Laboratory, 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
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964267 · Trionix Research Laboratory, Inc. · Nov 1996