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 the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. It received FDA 510(k) clearance on 2023-06-20 under 510(k) 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. The listed applicant is Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. The 510(k) number is K230346.

When did Voluson SWIFT; Voluson SWIFT+ receive FDA 510(k) clearance?

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

Who is the listed applicant for Voluson SWIFT; Voluson SWIFT+?

The FDA 510(k) record lists Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

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.

Official Source

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