Voluson™ Performance 16; Voluson™ Performance 18
K-Number: K250543 · 2025-05-29
Device Summary
Frequently Asked Questions
What is the Voluson™ Performance 16; Voluson™ Performance 18?
Voluson™ Performance 16; Voluson™ Performance 18 is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K250543.
When did Voluson™ Performance 16; Voluson™ Performance 18 receive FDA 510(k) clearance?
Voluson™ Performance 16; Voluson™ Performance 18 received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250543.
Who is the listed applicant for Voluson™ Performance 16; Voluson™ Performance 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™ Performance 16; Voluson™ Performance 18?
The FDA product code for Voluson™ Performance 16; Voluson™ Performance 18 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.
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.