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FDA 510(k)

Elekta Unity

K-Number: K182076 · 2018-12-04

ApplicantElekta Limited
Decision Date2018-12-04
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 Limited. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K182076. 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 2018-12-04. The listed applicant is Elekta Limited. The 510(k) number is K182076.

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

Elekta Unity received FDA 510(k) clearance on 2018-12-04, under 510(k) number K182076.

Who is the listed applicant for Elekta Unity?

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 Unity?

The FDA product code for Elekta Unity 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.

K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDK192482Elekta UnityK192242Synergy Platform, Synergy, Infinity, VersaHDK190178Monaco RTP SystemK183037Monaco RTP SystemK183034MOSAIQ Oncology Information System

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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.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

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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