Cleared Traditional

K954874 - SPECTEF PROTOCOL

K954874 is an FDA 510(k) clearance for SPECTEF PROTOCOL, 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 125-day FDA review.

K954874 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
125d
Days
Class 2
Risk

K954874 is an FDA 510(k) clearance for the SPECTEF PROTOCOL. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 26, 1996 after a review of 125 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 - K954874

510(k) Number K954874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1995
Decision Date February 26, 1996
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
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 K954874.
POSITRON COINCIDENCE DETECTION
K960192 · Philips Medical Systems (Cleveland), Inc. · Sep 1996
PRISM 3000XPV SYSTEM (210714)
K961577 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
XENON OPTION TO PRISM 3000
K955484 · Philips Medical Systems (Cleveland), Inc. · Mar 1996
SPECTRADIGITAL SERIES V250DSP
K954129 · Hitachi Medical Corp. of America · Dec 1995
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
K954143 · Hitachi Medical Corp. of America · Dec 1995
VERTEX EPIC MCD
K952684 · Adac Laboratories · Nov 1995