Cleared Traditional

COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION (K944720) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944720 · Nuccardiac Software, Inc. · Radiology device
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Dec 1994
Decision
91d
Days
Class 2
Risk

K944720 is an FDA 510(k) clearance for the COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Nuccardiac Software, Inc. (Torba Linda, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 91 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 Nuccardiac Software, Inc. devices

Submission Details

510(k) Number K944720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date December 23, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K944720.
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NON-UNIFORM ATTENUATION CORRECTION SYSTEM
K942145 · Siemens Medical Solutions USA, Inc. · Feb 1995
ADVANCE ANALYSIS SOFTWARE
K941223 · General Electric Co. · Nov 1994
PATLAK & FDG AUTORADIOGRAPHIC
K936001 · GE Medical Systems · Sep 1994
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
K942146 · Siemens Medical Solutions USA, Inc. · Sep 1994