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FDA 510(k)

Voluson SWIFT, Voluson SWIFT+

K-Number: K201828 · 2020-10-11

Decision Date2020-10-11
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 and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-10-11 under 510(k) number K201828. 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 2020-10-11. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K201828.

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

Voluson SWIFT, Voluson SWIFT+ received FDA 510(k) clearance on 2020-10-11, under 510(k) number K201828.

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

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics 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.

Other records listing GE Medical Systems Ultrasound and Primary Care Diagnostics as applicant

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.

View all 64 devices →

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

View on FDA Database →

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