Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
K-Number: K210500 · 2021-06-11
Device Summary
Frequently Asked Questions
What is the Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Elekta Limited. The 510(k) number is K210500.
When did Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD receive FDA 510(k) clearance?
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210500.
Who is the listed applicant for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?
The FDA 510(k) record lists Elekta Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD?
The FDA product code for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD is IYE.
Other records listing Elekta Limited 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: IYE)
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.