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FDA 510(k)

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch

K-Number: K182050 · 2018-10-03

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-10-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2018-10-03 under approval number K182050. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch?

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K182050.

When was Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch approved by the FDA?

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch received FDA 510(k) clearance on 2018-10-03, under approval number K182050.

What company makes Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch?

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch?

The FDA product code for Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch is IYE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41502788 Translational Evaluation of a Machine Learning-Based Interactive Lab for Aphasia Rehabilitation in Post Stroke Patients. IEEE journal of translational engineering in health and medicine (2025)

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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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