Cleared Traditional

K020913 - CT-C3000 SPIRAL CT SCANNER SYSTEM

K020913 is an FDA 510(k) clearance for CT-C3000 SPIRAL CT SCANNER SYSTEM, manufactured by Neusoft Digital Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K020913 · Neusoft Digital Medical Systems Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2002
Decision
13d
Days
Class 2
Risk

K020913 is an FDA 510(k) clearance for the CT-C3000 SPIRAL CT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Neusoft Digital Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on April 3, 2002 after a review of 13 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 Neusoft Digital Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K020913

510(k) Number K020913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2002
Decision Date April 03, 2002
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
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 Peers - JAK System, X-ray, Tomography, Computed

All 686
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