Versana Premier
K-Number: K210438 · 2021-09-10
Device Summary
Frequently Asked Questions
What is the Versana Premier?
Versana Premier is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K210438.
When did Versana Premier receive FDA 510(k) clearance?
Versana Premier received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210438.
Who is the listed applicant for Versana Premier?
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 Versana Premier?
The FDA product code for Versana Premier 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.