FDA 510(k)

LINACwatch, LinacView

K-Number: K172534 · 2017-10-27

Decision Date2017-10-27

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LINACwatch, LinacView is the device name listed in this FDA 510(k) record. The listed applicant is Qualiformed Sarl. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172534. 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 LINACwatch, LinacView?

LINACwatch, LinacView is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Qualiformed Sarl. The 510(k) number is K172534.

When did LINACwatch, LinacView receive FDA 510(k) clearance?

LINACwatch, LinacView received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172534.

Who is the listed applicant for LINACwatch, LinacView?

The FDA 510(k) record lists Qualiformed Sarl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINACwatch, LinacView?

The FDA product code for LINACwatch, LinacView is IYE.

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 SA K253004LUNA 3DLap GmbH Laser Applikationen K260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC K252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla K253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.