Cleared Traditional

K921777 - CARDIAC FIRST PASS ANALYSIS

K921777 is an FDA 510(k) clearance for CARDIAC FIRST PASS ANALYSIS, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K921777 · GE Medical Systems · Radiology device
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Aug 1992
Decision
120d
Days
Class 2
Risk

K921777 is an FDA 510(k) clearance for the CARDIAC FIRST PASS ANALYSIS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on August 12, 1992 after a review of 120 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 GE Medical Systems devices

FDA 510(k) Submission Details - K921777

510(k) Number K921777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date August 12, 1992
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
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 250
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K921777.
ARGUS PET SYSTEM
K923309 · GE Medical Systems · Sep 1992
MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM
K922372 · Siemens Gammasonics, Inc. · Aug 1992
MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM
K922373 · Siemens Gammasonics, Inc. · Aug 1992
GENESYS II
K922080 · Adac Laboratories · Jul 1992
GE 4096 PLUS & GE 2048
K914267 · GE Medical Systems · Jul 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
K915470 · General Electric Co. · Apr 1992