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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Rheinland of North America, Inc.
WOLFRAM GMELIN

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 822
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K020913.
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K020913 · CT-C3000 SPIRAL CT SCANNER SYSTEM
Download PDF FDA Summary Neusoft Digital Medic…