Cleared Traditional

K962955 - GAMMACON IMAGE TRANSLATION SYSTEM

K962955 is an FDA 510(k) clearance for GAMMACON IMAGE TRANSLATION SYSTEM, manufactured by Medical Imaging Technology Assoc., 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.

K962955 · Medical Imaging Technology Assoc., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
90d
Days
Class 2
Risk

K962955 is an FDA 510(k) clearance for the GAMMACON IMAGE TRANSLATION SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Medical Imaging Technology Assoc., Inc. (Mainland, US). The FDA issued a Cleared decision on October 28, 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 Medical Imaging Technology Assoc., Inc. devices

FDA 510(k) Submission Details - K962955

510(k) Number K962955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1996
Decision Date October 28, 1996
Days to Decision 90 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
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 356
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K962955.
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
TRIAD 88 NUCLEAR IMAGING SYSTEM
K964268 · Trionix Research Laboratory, Inc. · Nov 1996
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
STEP OPTION TO PRISM 2000
K960865 · Philips Medical Systems (Cleveland), Inc. · Sep 1996