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FDA 510(k)

syngo Application Software VD11

K-Number: K153346 · 2016-03-04

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-03-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software VD11 is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K153346. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo Application Software VD11?

syngo Application Software VD11 is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K153346.

When was syngo Application Software VD11 approved by the FDA?

syngo Application Software VD11 received FDA 510(k) clearance on 2016-03-04, under approval number K153346.

What company makes syngo Application Software VD11?

syngo Application Software VD11 is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo Application Software VD11?

The FDA product code for syngo Application Software VD11 is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Other Devices by Siemens Medical Solutions USA, Inc.

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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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