FDA 510(k)

Voluson Signature 20, Voluson Signature 18

K-Number: K233692 · 2024-03-07

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics

Decision Date2024-03-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Voluson Signature 20, Voluson Signature 18 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 2024-03-07 under 510(k) number K233692. 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 Signature 20, Voluson Signature 18?

Voluson Signature 20, Voluson Signature 18 is a medical device that received FDA 510(k) clearance on 2024-03-07. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K233692.

When did Voluson Signature 20, Voluson Signature 18 receive FDA 510(k) clearance?

Voluson Signature 20, Voluson Signature 18 received FDA 510(k) clearance on 2024-03-07, under 510(k) number K233692.

Who is the listed applicant for Voluson Signature 20, Voluson Signature 18?

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 Signature 20, Voluson Signature 18?

The FDA product code for Voluson Signature 20, Voluson Signature 18 is IYN.

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

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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.