FDA 510(k)

Voluson SWIFT; Voluson SWIFT+

K-Number: K230346 · 2023-06-20

ApplicantGe Medical Systems Ultrasound & Primary Care Diagnostic, LLC

Decision Date2023-06-20

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Voluson SWIFT; Voluson SWIFT+ is a medical device manufactured by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. It received FDA 510(k) clearance on 2023-06-20 under approval number K230346. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voluson SWIFT; Voluson SWIFT+?

Voluson SWIFT; Voluson SWIFT+ is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. The 510(k) number is K230346.

When was Voluson SWIFT; Voluson SWIFT+ approved by the FDA?

Voluson SWIFT; Voluson SWIFT+ received FDA 510(k) clearance on 2023-06-20, under approval number K230346.

What company makes Voluson SWIFT; Voluson SWIFT+?

Voluson SWIFT; Voluson SWIFT+ is manufactured by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC.

What is the FDA product code for Voluson SWIFT; Voluson SWIFT+?

The FDA product code for Voluson SWIFT; Voluson SWIFT+ is IYN.

Related Devices (Code: IYN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.