Cleared Traditional

K043381 - INFINIA LIGHTSPEED

K043381 is an FDA 510(k) clearance for INFINIA LIGHTSPEED, manufactured by Ge Medical Systems F.I. Haifa. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K043381 · Ge Medical Systems F.I. Haifa · Radiology device
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Dec 2004
Decision
14d
Days
Class 2
Risk

K043381 is an FDA 510(k) clearance for the INFINIA LIGHTSPEED. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 23, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 F.I. Haifa devices

FDA 510(k) Submission Details - K043381

510(k) Number K043381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2004
Decision Date December 23, 2004
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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

Underwriters Laboratories, Inc.
ALEX GROB

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 - KPS System, Tomography, Computed, Emission

All 404
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K043381.
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