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FDA 510(k)

syngo Ultrasound Apps Suite (sUSAS)

K-Number: K201062 · 2020-05-18

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-05-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo Ultrasound Apps Suite (sUSAS) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-05-18 under 510(k) number K201062. 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 Ultrasound Apps Suite (sUSAS)?

syngo Ultrasound Apps Suite (sUSAS) is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K201062.

When did syngo Ultrasound Apps Suite (sUSAS) receive FDA 510(k) clearance?

syngo Ultrasound Apps Suite (sUSAS) received FDA 510(k) clearance on 2020-05-18, under 510(k) number K201062.

Who is the listed applicant for syngo Ultrasound Apps Suite (sUSAS)?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo Ultrasound Apps Suite (sUSAS)?

The FDA product code for syngo Ultrasound Apps Suite (sUSAS) is LLZ.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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