Cleared Traditional

K000300 - LIGHTSPEED 2.0CT SCANNER SYSTEM

K000300 is an FDA 510(k) clearance for LIGHTSPEED 2.0CT SCANNER 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 15-day FDA review.

K000300 · Ge Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
15d
Days
Class 2
Risk

K000300 is an FDA 510(k) clearance for the LIGHTSPEED 2.0CT SCANNER 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 February 15, 2000 after a review of 15 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 - K000300

510(k) Number K000300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2000
Decision Date February 15, 2000
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
LUDGEV MOELLER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K000300.
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc. · Jun 2000
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
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645 · Ge Medical Systems, Inc. · Dec 1999
CT PERFUSION OPTION
K993791 · Ge Medical Systems, Inc. · Nov 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792 · Ge Medical Systems, Inc. · Nov 1999