Cleared Traditional

K944013 - CT PROSPEED FAMILY

K944013 is an FDA 510(k) clearance for CT PROSPEED FAMILY, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K944013 · GE Medical Systems · Radiology device
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Feb 1995
Decision
175d
Days
Class 2
Risk

K944013 is an FDA 510(k) clearance for the CT PROSPEED FAMILY. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 175 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K944013

510(k) Number K944013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date February 07, 1995
Days to Decision 175 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
68d slower than avg
Panel avg: 107d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K944013.
PHILIPS TOMOSCAN SR 8000
K954255 · Philips Medical Systems North America, Inc. · Oct 1995
PQ5000 CT SYSTEM
K943623 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
HRSW OPTION FOR CT TWIN FLASH
K945512 · Elscint, Inc. · Mar 1995
ANATOM 2000
K944131 · Analogic Corp. · Jan 1995
MEDRAD COUNTERPOISE SYSTEM
K944983 · Medrad, Inc. · Nov 1994
PHILIPS TOMOSCAN SR5000
K944326 · Philips Medical Systems North America, Inc. · Oct 1994