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FDA 510(k)

Voluson Signature 20, Voluson Signature 18

K-Number: K233692 · 2024-03-07

Decision Date2024-03-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

When was Voluson Signature 20, Voluson Signature 18 approved by the FDA?

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

What company makes Voluson Signature 20, Voluson Signature 18?

Voluson Signature 20, Voluson Signature 18 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

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.

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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.