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FDA 510(k)

Elekta Unity

K-Number: K212114 · 2021-10-01

ApplicantElekta Solutions AB
Decision Date2021-10-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Elekta Unity is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K212114. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elekta Unity?

Elekta Unity is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Elekta Solutions AB. The 510(k) number is K212114.

When did Elekta Unity receive FDA 510(k) clearance?

Elekta Unity received FDA 510(k) clearance on 2021-10-01, under 510(k) number K212114.

Who is the listed applicant for Elekta Unity?

The FDA 510(k) record lists Elekta Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elekta Unity?

The FDA product code for Elekta Unity is IYE.

Other records listing Elekta Solutions AB as applicant

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K261932Leksell® Vantage Stereotactic SystemK252002Monaco RTP System (6.3)K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K251363ProKnow DSK250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)K232854Leksell GammaPlan (LGP)

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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.

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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.

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