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FDA 510(k)

XVI R5.0

K-Number: K131965 · 2013-09-25

ApplicantElekta Limited
Decision Date2013-09-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XVI R5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Limited. It received FDA 510(k) clearance on 2013-09-25 under 510(k) number K131965. 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 XVI R5.0?

XVI R5.0 is a medical device that received FDA 510(k) clearance on 2013-09-25. The listed applicant is Elekta Limited. The 510(k) number is K131965.

When did XVI R5.0 receive FDA 510(k) clearance?

XVI R5.0 received FDA 510(k) clearance on 2013-09-25, under 510(k) number K131965.

Who is the listed applicant for XVI R5.0?

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 XVI R5.0?

The FDA product code for XVI R5.0 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, VersaHDK182076Elekta UnityK112613INTEGRITY(TM)K111676APEX

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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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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