Cleared Traditional

K993645 - CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM

K993645 is an FDA 510(k) clearance for CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K993645 · Ge Medical Systems, Inc. · Radiology device
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Dec 1999
Decision
54d
Days
Class 2
Risk

K993645 is an FDA 510(k) clearance for the CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K993645

510(k) Number K993645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1999
Decision Date December 21, 1999
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
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 K993645.
PHILIPS CT SECURA MV
K000819 · Philips Medical Systems North America, Inc. · May 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · Shimadzu Medical Systems · Mar 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · Ge Medical Systems, Inc. · Feb 2000
CT PERFUSION OPTION
K993791 · Ge Medical Systems, Inc. · Nov 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · Ge Medical Systems, Inc. · Nov 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764 · Siemens Medical Solutions USA, Inc. · Aug 1999