LINACwatch, LinacView

FDA 510(k) K172534 · Qualiformed Sarl

Substantially Equivalent

510(k) numberK172534

Submission

Device name
LINACwatch, LinacView
Applicant
Qualiformed Sarl
La Roche Sur Yon, FR
Received
August 22, 2017
Decision date
October 27, 2017
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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Questions and answers

When was LINACwatch, LinacView cleared by the FDA?

LINACwatch, LinacView (K172534) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 66 days after the submission was received.

What is the product code of K172534?

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