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FDA 510(k)

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K-Number: K252328 · 2025-11-24

Decision Date2025-11-24
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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

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