Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

syngo Application Software

K-Number: K230955 · 2023-12-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Application Software is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K230955. 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?

syngo Application Software is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K230955.

When was syngo Application Software approved by the FDA?

syngo Application Software received FDA 510(k) clearance on 2023-12-20, under approval number K230955.

What company makes syngo Application Software?

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

What is the FDA product code for syngo Application Software?

The FDA product code for syngo Application Software is LLZ.

Related Clinical Trials

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow RECRUITING NCT06257069 Tremor Retrainer Software Application for Functional Tremor ACTIVE_NOT_RECRUITING NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED NCT06052891 CHAMP For the Feeder: Tube Feeding Study ENROLLING_BY_INVITATION NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED

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.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

View all 248 devices →

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑