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FDA 510(k)

ACUSON NX2 Diagnostic Ultrasound Systems

K-Number: K161787 · 2016-07-28

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-07-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON NX2 Diagnostic Ultrasound Systems is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K161787. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON NX2 Diagnostic Ultrasound Systems?

ACUSON NX2 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K161787.

When was ACUSON NX2 Diagnostic Ultrasound Systems approved by the FDA?

ACUSON NX2 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2016-07-28, under approval number K161787.

What company makes ACUSON NX2 Diagnostic Ultrasound Systems?

ACUSON NX2 Diagnostic Ultrasound Systems is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ACUSON NX2 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON NX2 Diagnostic Ultrasound Systems is IYN.

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

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Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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