Cleared Traditional

K944720 - COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION

K944720 is an FDA 510(k) clearance for COMPUTER, manufactured by Nuccardiac Software, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K944720

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.

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 K944720.
VANTAGE, FOR ADAC GAMMA CAMERAS
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K945652 · GE Medical Systems · Mar 1995
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