Cleared Traditional

K161787 - ACUSON NX2 Diagnostic Ultrasound Systems

K161787 is an FDA 510(k) clearance for ACUSON NX2 Diagnostic Ultrasound Systems, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K161787 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
29d
Days
Class 2
Risk

K161787 is an FDA 510(k) clearance for the ACUSON NX2 Diagnostic Ultrasound Systems. 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. (Moutain View, US). The FDA issued a Cleared decision on July 28, 2016 after a review of 29 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. devices

FDA 510(k) Submission Details - K161787

510(k) Number K161787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2016
Decision Date July 28, 2016
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1089
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161787.
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · FUJIFILM Sonosite, Inc. · Aug 2016
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
K161224 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Aug 2016
Vivid iq
K161706 · Ge Medical Systems Ultrasound and Primary Care Diagnostics L · Aug 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · Esaote, S.P.A. · Jul 2016
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2016
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
K160853 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Jun 2016