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Siemens Healthineers Ms. Christine Dunbar Sr. Regulatory Affairs Specialist 22010 SE 51 Street ISSAQUAH WA 98029March 20, 2019Re: K183575 Trade/Device Name: ACU SON S3000, S2000 Diagnostic Ultrasound

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Companies or individuals seeking to obtain FDA clearance for a medical device generally need to submit an 008510k summary PDF. This summary document is part of the premarket submission process required by the United States Food and Drug Administration (FDA). It is necessary for manufacturers intending to market a new medical device or make significant modifications to an existing device. The 008510k summary PDF provides a concise overview of the device, its intended use, and any modifications made, along with supporting data to justify its safety and effectiveness.

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