Cleared Traditional

K053084 - SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

K053084 is an FDA 510(k) clearance for SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM, manufactured by Kontron Medical Systems Sas. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K053084 · Kontron Medical Systems Sas · Radiology device
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Nov 2005
Decision
14d
Days
Class 2
Risk

K053084 is an FDA 510(k) clearance for the SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Kontron Medical Systems Sas (Redmond, US). The FDA issued a Cleared decision on November 16, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Kontron Medical Systems Sas devices

FDA 510(k) Submission Details - K053084

510(k) Number K053084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date November 16, 2005
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
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.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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