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FDA 510(k)

syngo Application Software (VE21)

K-Number: K220433 · 2022-08-16

ApplicantSiemens Medical Solution USA, Inc.
Decision Date2022-08-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software (VE21) is a medical device manufactured by Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2022-08-16 under approval number K220433. 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 (VE21)?

syngo Application Software (VE21) is a medical device that received FDA 510(k) clearance on 2022-08-16. It is manufactured by Siemens Medical Solution USA, Inc.. The 510(k) number is K220433.

When was syngo Application Software (VE21) approved by the FDA?

syngo Application Software (VE21) received FDA 510(k) clearance on 2022-08-16, under approval number K220433.

What company makes syngo Application Software (VE21)?

syngo Application Software (VE21) is manufactured by Siemens Medical Solution USA, Inc..

What is the FDA product code for syngo Application Software (VE21)?

The FDA product code for syngo Application Software (VE21) 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 Solution USA, Inc.

K163286ARTIS pheno K163285syngo Application Software K181407Artis zee/zeego & Artis Q/Q.zen K190780syngo Application Software K190757MAGNETOM Avanto Fit K201156ARTIS pheno (VE2)

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Related Devices (Code: LLZ)

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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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