Elekta Unity

FDA 510(k) K212114 · Elekta Solutions AB

Substantially Equivalent

510(k) numberK212114

Submission

Device name
Elekta Unity
Applicant
Elekta Solutions AB
Stockholm, SE
Received
July 7, 2021
Decision date
October 1, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Elekta Unity cleared by the FDA?

Elekta Unity (K212114) received a 510(k) decision of Substantially Equivalent on October 1, 2021, 86 days after the submission was received.

What is the product code of K212114?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.