Cleared Traditional

K090334 - ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM

K090334 is the FDA 510(k) clearance for ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM by Siemens Medi Cal Solutions, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K090334 · Siemens Medi Cal Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
10d
Days
Class 2
Risk

K090334 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 Medi Cal Solutions, Inc. (Mountainview, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 10 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 Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K090334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date February 20, 2009
Days to Decision 10 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
97d faster than avg
Panel avg: 107d · This submission: 10d
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

All 780
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K090334.
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179 · Toshiba America Medical Systems, In.C · Jul 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
K091009 · Esaote, S.P.A. · May 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · Siemens Medical Solutions USA, Inc. · Mar 2009
APLIO ARTIDA V2.0 SSH-880CV
K090158 · Toshiba America Medical Systems, In.C · Feb 2009
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K083254 · Aloka Co., Ltd. · Dec 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2008