Alignrt Plus

FDA 510(k) K123371 · Vision RT Limited

Substantially Equivalent

510(k) numberK123371

Submission

Device name
Alignrt Plus
Applicant
Vision RT Limited
London, GB
Received
November 1, 2012
Decision date
January 8, 2013
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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More from Varian Medical Systems, Inc.

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K253012AlignRT Plus (8.0)IYE · Traditional 03/18/2026SE
K243301MapRTIYE · Traditional 05/19/2025SE
K233622AlignRT PlusIYE · Traditional 03/29/2024SE
K231185MapRTIYE · Traditional 06/23/2023SE
K212583AlignRT PlusIYE · Traditional 11/10/2021SE
K203387AlignRT PlusIYE · Traditional 03/04/2021SE
K193431AlignRT PlusIYE · Special 01/03/2020SE
K181218AlignRT PlusIYE · Traditional 08/07/2018SE
K072171Gatect-RtIYE · Traditional 10/01/2007SE
K052682AlignrtIYE · Traditional 01/06/2006SE

Questions and answers

When was Alignrt Plus cleared by the FDA?

Alignrt Plus (K123371) received a 510(k) decision of Substantially Equivalent on January 8, 2013, 68 days after the submission was received.

What is the product code of K123371?

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