Cleared Traditional

K112596 - ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM

K112596 is the FDA 510(k) clearance for ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K112596 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Radiology device
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Sep 2011
Decision
9d
Days
Class 2
Risk

K112596 is an FDA 510(k) clearance for the ACUSON S2000 DIAGNOSTIC 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 Siemens Medical Solutions USA, Inc., Ultrasound DI (Mountainview, US). The FDA issued a Cleared decision on September 16, 2011 after a review of 9 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 Siemens Medical Solutions USA, Inc., Ultrasound DI devices

Submission Details

510(k) Number K112596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date September 16, 2011
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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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