FDA 510(k)

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K-Nummer: K252328 · 2025-11-24

AntragstellerGE Medical Systems Ultrasound and Primary Care Diagnostics

Entscheidungsdatum2025-11-24

ProduktcodeIYN

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 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 2025-11-24 under 510(k) number K252328. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K252328.

When did Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 receive FDA 510(k) clearance?

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252328.

Who is the listed applicant for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

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 Expert 18; Voluson Expert 20; Voluson Expert 22?

The FDA product code for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is IYN.

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