Cleared Traditional

K132654 - ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

K132654 is the FDA 510(k) clearance for ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc. Ultrasound Gro. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K132654 · Siemens Medical Solutions USA, Inc. Ultrasound Gro · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
31d
Days
Class 2
Risk

K132654 is an FDA 510(k) clearance for the ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. Ultrasound Gro (Moutain View, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Gro devices

Submission Details

510(k) Number K132654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2013
Decision Date September 26, 2013
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 390
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K132654.
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
K140291 · Volcano Corporation · Mar 2014
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE
K133641 · Volcano Corporation · Dec 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
K133142 · Volcano Corporation · Nov 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · Edan Instruments, Inc. · Sep 2013
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
K132228 · Samsung Medison Co., Ltd. · Aug 2013
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013