Cleared Traditional

K072786 - ACUSON S2000 ULTRASOUND SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072786 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
43d
Days
Class 2
Risk

K072786 is an FDA 510(k) clearance for the ACUSON S2000 ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 13, 2007 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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. devices

Submission Details

510(k) Number K072786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date November 13, 2007
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 408
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K072786.
ULTRASONIC PROBE UM-3R (UM-3R)
K250883 · Olympus Medical Systems Corporation · Sep 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · Olympus Medical Systems Corporation · Jul 2025
Mendaera Guidance System
K250524 · Mendaera, Inc. · Jul 2025
Accuro® 3S Needle Guide Kit
K250469 · Rivanna Medical, Inc. · Jun 2025
Ultrasound Transducer Cover
K241662 · Vitrolife Sweden AB · Aug 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · Parker Laboratories, Inc. · Aug 2024