Cleared Traditional

K040372 - LIGHTSPEED 7.0 CT SCANNER SYSTEM

K040372 is an FDA 510(k) clearance for LIGHTSPEED 7.0 CT SCANNER SYSTEM, manufactured by Ge Medical Systems, LLC. 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.

K040372 · Ge Medical Systems, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
13d
Days
Class 2
Risk

K040372 is an FDA 510(k) clearance for the LIGHTSPEED 7.0 CT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on March 1, 2004 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 Ge Medical Systems, LLC devices

FDA 510(k) Submission Details - K040372

510(k) Number K040372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date March 01, 2004
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.
JUERGEN WELTE

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 736
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K040372.
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665 · Siemens Medical Solutions USA, Inc. · Apr 2004
SOMATOM PROJECT P30L
K040577 · Siemens Medical Systems, Inc. · Mar 2004
CT-MASS
K033774 · Medis Medical Imaging Systems BV · Mar 2004
BRAIN PERFUSION OPTION
K033677 · Philips Medical Systems (Cleveland), Inc. · Feb 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · Philips Medical Systems (Cleveland), Inc. · Jan 2004
SYNGO PERFUSION-CT
K033832 · Siemens AG Medical Solutions · Dec 2003