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FDA 510(k)

AlignRT Plus

K-Number: K212583 · 2021-11-10

ApplicantVision Rt, Ltd.
Decision Date2021-11-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AlignRT Plus is the device name listed in this FDA 510(k) record. The listed applicant is Vision Rt, Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212583. 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 AlignRT Plus?

AlignRT Plus is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Vision Rt, Ltd.. The 510(k) number is K212583.

When did AlignRT Plus receive FDA 510(k) clearance?

AlignRT Plus received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212583.

Who is the listed applicant for AlignRT Plus?

The FDA 510(k) record lists Vision Rt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AlignRT Plus?

The FDA product code for AlignRT Plus is IYE.

Other records listing Vision Rt, Ltd. 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.

K253012AlignRT Plus (8.0)K243301MapRTK233622AlignRT PlusK231185MapRTK203387AlignRT PlusK193431AlignRT Plus

View all 8 devices →

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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